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WO2019236415A1 - Scope à usages multiples avec micro-dels - Google Patents

Scope à usages multiples avec micro-dels Download PDF

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Publication number
WO2019236415A1
WO2019236415A1 PCT/US2019/034954 US2019034954W WO2019236415A1 WO 2019236415 A1 WO2019236415 A1 WO 2019236415A1 US 2019034954 W US2019034954 W US 2019034954W WO 2019236415 A1 WO2019236415 A1 WO 2019236415A1
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WO
WIPO (PCT)
Prior art keywords
endoscope
distal
tissue
computer
tne
Prior art date
Application number
PCT/US2019/034954
Other languages
English (en)
Inventor
Joel FRIEDLANDER
Jeremy PRAGER
Emily DEBOER
Robin DETERDING
Original Assignee
The Regents Of The University Of Colorado, A Body Corporate
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Regents Of The University Of Colorado, A Body Corporate filed Critical The Regents Of The University Of Colorado, A Body Corporate
Publication of WO2019236415A1 publication Critical patent/WO2019236415A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00039—Operational features of endoscopes provided with input arrangements for the user
    • A61B1/00042—Operational features of endoscopes provided with input arrangements for the user for mechanical operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00039—Operational features of endoscopes provided with input arrangements for the user
    • A61B1/0004—Operational features of endoscopes provided with input arrangements for the user for electronic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00002—Operational features of endoscopes
    • A61B1/00043—Operational features of endoscopes provided with output arrangements
    • A61B1/00045—Display arrangement
    • A61B1/0005—Display arrangement combining images e.g. side-by-side, superimposed or tiled
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/00078—Insertion part of the endoscope body with stiffening means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00087—Tools
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00097—Sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
    • A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0638—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements providing two or more wavelengths
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0676—Endoscope light sources at distal tip of an endoscope
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/06—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with illuminating arrangements
    • A61B1/0661—Endoscope light sources
    • A61B1/0684—Endoscope light sources using light emitting diodes [LED]

Definitions

  • This invention relates to a device and its uses for evaluating multiple conditions.
  • a device as described herein may be capable of being used for multiple end uses, including for example, an endoscope, such as a nasal endoscope, a triple endoscope, a bronchoscope, a laryngoscope, a gastroscope, an aerodigestive scope, and/or an endoscopic device used to visualize any body cavity to which it would fit.
  • an endoscope such as a nasal endoscope, a triple endoscope, a bronchoscope, a laryngoscope, a gastroscope, an aerodigestive scope, and/or an endoscopic device used to visualize any body cavity to which it would fit.
  • devices may encompass multiple functionalities while maintaining specific sizes to allow for ease of use and/or patient comfort.
  • veterinary medicine and/or medicine such as in pediatrics or small adults
  • the evaluation and treatment of eosinophilic esophagitis, esophagitis, gastritis, celiac disease, gastric infection, gastric ulcer, duodenal ulcer and aerodigestive conditions in children, small adults, and in outpatient or emergent settings where a gastrointestical procedural suite or operating room are not available may be of particular interest.
  • some embodiments of this invention may relate to pediatric or adult nasal endoscopes.
  • Eosinophilic esophagitis is an increasingly common chronic inflammatory disease that affects children and adults with an estimated incidence of 1/10,000 in the United States.
  • EoE Eosinophilic esophagitis
  • ACG clinical guideline Evidenced based approach to the diagnosis and management of esophageal eosinophilia and eosinophilic esophagitis (EoE).
  • TNE transnasal endoscopy/esophagoscopy
  • TNE offers advantages including that it can be performed in an outpatient clinic room, requires no anesthesia or sedation, uses an adult transnasal gastroscope that is tolerated by adults and procures samples adequate for assessment of Barrett’s Esophagus.
  • Randomized crossover study comparing efficacy of transnasal endoscopy with that of standard endoscopy to detect Barrett’s esophagus. Gastrointest Endosc 20l2;75:954- 61; Saeian K, Staff DM, Vasilopoulos S, et al.
  • Unsedated transnasal endoscopy accurately detects Barrett’s metaplasia and dysplasia. Gastrointest Endosc 2002;56:472-8]
  • the endoscopes used in the adult procedures are not appropriate for use in pediatric setting.
  • Adult endoscopes and nasal endoscopes have a large bulky head, will not fit in many pediatric size or small adult nasal passages, are hard to control by individuals with small hands, do not have optional stiffening capability for improved maneuverability, do not have foot controls or a full array of hand button controls, are not connected to or allow voice dictation of reports, are not able to be used in pediatrics or small adults, and are unable to be used for bronchoscopy.
  • a device and associated methodology that can be used to adapt TNE to assess the esophageal mucosa, gastric, and duodenal, tracheal, and bronchial mucosa in children and small adults in both a sedated and unsedated manner with a a full array of steering and a channel large enough to enable full evaluation of the above tissues.
  • the present invention provides tools and techniques to meet this important need.Light may be used in medical devices to aid treatment or diagnose conditions with endoscopic technologies. In particular, light may be used on probes to stimulate tissue.
  • gallium nitride microLEDs have been used on probes to stimulate light sensitive tissue as is disclosed by McAlinden (McAlinden, Niall and Massoubre, David and Richardson, Elliot and Gu, Erdan and Sakata, Shuzo and Dawson, Martin D and Mathieson, Keith (2013) Thermal and optical characterization of micro-LED probes for in vivo optogenetic neural stimulation. Optics Letters, 38 (6). pp. 992-994. http :/7dx. doi . orgy 10.1364/OL 38 000992) which is incorporated by reference.
  • An embodiment of the invention includes a flexible endoscope approximately 1-1.2 meter in length and having an outer diameter in a range from about 3 mm to about 5 mm that allows high resolution, high definition, and clear optics of the nasal mucosa, pharynx and upper gastrointestinal tract with the head of a bronchoscope that allows four way tip deflection to allow use by individuals with varying hand sizes, an optional foot pedal to allow air/water insufflation for ease of use, a bright light source, an optional scope stiffening apparatus that will allow utilization in aerodigestive medicine (combined ENT-laryngoscopy, Pulmonary (bronchoscopy), and Gastroenterology (EGD) Procedures), an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance
  • the device may be designed for smaller sized orifices, as in pediatrics.
  • An embodiment of the invention includes a miniaturized 3-4 mm flexible or 4-5 mm, endoscope approximately 1-1.2 meter in length that allows high resolution, high definition, and clear optics of the nasal mucosa, pharynx and upper gastrointestinal tract with the small head of a pediatric bronchoscope that allows four way tip deflection to allow use by individuals with small hand sizes, an optional foot pedal to allow air/water insufflation for ease of use, a bright light source, an optional scope stiffening apparatus that will allow utilization in aerodigestive medicine (combined ENT -laryngoscopy, Pulmonary (bronchoscopy), and Gastroenterology (EGD) Procedures), an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to map and measure objects in the body cavity, a microphone to allow dictation into a reporting system and/or voice activation, and a
  • Scopes may benefit from the use of energy and/or light in order to visualize, activate materials, and/or detect within an enclosed environment.
  • Sources capable of delivering controlled energy and/or light may be used to deliver such energy to a predetermined location. By controlling properties of the energy delivered it is possible, for example, to control images of the enclosed environment, to enable detection of particular predetermined conditions, and in some instances to treat.
  • Light sources or elements used in conjunction with the scope may include micro light emitting diodes (pLEDs or microLEDs) light sources.
  • pLEDs or microLEDs micro light emitting diodes
  • use of microLEDs on a scope for medical use may enable improved visuals of predetermined sites within a patient and/or model, enhanced diagnostic outcomes and/or treatment scenarios for patients.
  • An endoscopic device may include a control element having ports, interface elements; and indicators.
  • the control element may be coupled to an elongated element that is also coupled to a distal element.
  • the elongated element may have a cross-sectional outer diameter of less than about 3.5 millimeter. In some instances, the elongated element may have a cross-sectional outer diameter in a range between 4 to 5 mm.
  • the elongated element may include a conduit, in particular, a non-collapsible conduit having a diameter in a range between about 1.0 to about 2.5 millimeters in diameter. In some instances, the non-collapsible conduit may have a diameter in a range from about 2.8 to 3.2 mm for a larger catheter shaft design.
  • the distal element may include an illumination element, an optical element that will transmit images and/or video (via wires or wireless transmission) to an display (including video goggles) and a reporting system.
  • the reporting system may be voice activated and/or activated or controlled using interface elements.
  • the device may have a diameter of the non-collapsible conduit in a range from about 1.0 to about 3.55 millimeter. In some instances, the conduit may have a diameter in a range from about 2.8 to about 3.2 mm based on the tools utilized. Further, it may be useful for certain configurations of the device to have a diameter of the non-collapsible conduit in a range from about 1.3 mm to about 2.2 mm.
  • control element is optionally removable in some embodiments.
  • At least one of the interface elements of the control element is a four-way or greater distal element control mechanism.
  • a diameter of the non-collapsible conduit is in a range between about 1.3 mm to about 3.2 mm.
  • the diameter of the non-collapsible conduit may be selected based on the tools required for a given procedure and/or patient. Further, a size of the patient, orifices to be explored and/or simulator may be taken into account when sizing the endoscope and/or the non- collapsible conduit.
  • Optical elements for use in an embodiment have a field of view of at least eighty-five degrees and a depth of view of at least 5 mm. In some instances, the depth of view may exceed 100 mm.
  • a sound interface in the device and in particular, in the control element may be coupled to a computer system to allow for use of voice commands.
  • voice commands it may be possible to activate a dictation module during use of the device, so that the notes can be recorded.
  • voice activation may be used to activate any number of features of the device.
  • Sensors and/or elements may be configured to transmit data using wired and/or wireless connection. Sensors may be configured to interact with sensors and/or markers positioned on, in, or near a patient during use to determine a position or condition of the patient. For example, a distance and location sensor may interfaces with a computer system to note location and distance of a scope from the insertion point of the scope. A further sensor may measure a luminal diameter and surface features of a body cavity the scope is visualizing.
  • An endoscope system may include a removable control element having ports, interface elements, and indicators. Further, the endoscope may include an elongated element coupled to a control element having a cross-sectional outer diameter of less than four millimeter and including a conduit or channel having a diameter of at least 1.3 mm not greater than 2.2 mm. In some instances, the elongated element may have a conduit or channel having a diameter of at least 2.8 but not greater than 3.2 mm. Further the a distal element includes an illumination element and an optical element.
  • the system further includes a computer control unit having one or more device drivers. In addition, the system may include a computer and one or more display elements.
  • Audio elements such as microphones may be utilized to control functions of the system, including for example, the functioning of sensors. Further, audio elements may be used to facilitate auto-reporting, voice-activated commands, dictation, recording, and/or populating reports and/or databases.
  • An interface element may be configured to send data from at least one of the optical element, the audio element and the sensor array to a computer.
  • Patent law e.g., they can mean“includes”,“included”,“including”, and the like; and that terms such as“consisting essentially of’ and“consists essentially of’ have the meaning ascribed to them in U.S. Patent law, e.g., they allow for elements not explicitly recited, but exclude elements that are found in the prior art or that affect a basic or novel characteristic of the invention.
  • FIG. 1 is an image showing a biopsy with active EoE using a standard 2.8 mm EGD forceps.
  • the surface area is 0.10 mm 2 .
  • FIG. 2 is an image showing a biopsy from the same patient with active EoE using TNE 1.2 mm forceps.
  • the surface area is 0.12 mm 2 .
  • FIG. 3 is an image taken from a subject with active furrowing and eosinophilic exudates.
  • FIG. 4 is a drawing depicting an illustrative example of a pediatric nasal endoscope.
  • FIG. 5 is a drawing depicting an illustrative example of a pediatric nasal endoscope biopsy forceps.
  • FIG. 6 is a block diagram depicting a system that incorporates an endoscope.
  • FIG. 7A is an exploded view of an illustrative example of the distal and elongated elements of an endoscope.
  • FIG. 7B is an exploded view of an illustrative example of the distal and elongated elements of an endoscope.
  • FIG 8 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 9 is a drawing depicting a cross-sectional view of an illustrative example of a distal element for an endoscope.
  • FIG. 10 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG 11 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 12 is a drawing depicting a cross-sectional view of an illustrative example of a distal element for an endoscope.
  • FIG. 13 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG 14 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG 15 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG 16 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 17 is a drawing depicting a cross-sectional view of an illustrative example of a distal element for an endoscope.
  • FIG. 18 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG. 19 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG 20 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 21 is a drawing depicting a cross-sectional view of an illustrative example of a distal element for an endoscope.
  • FIG. 22 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG. 23 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG 24 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 25 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG. 26 is a drawing depicting a side view of an illustrative example of a distal element for an endoscope.
  • FIG 27 is a drawing depicting an end view of an illustrative example of a distal element for an endoscope.
  • FIG. 28 is a drawing depicting a cross-sectional view of an illustrative example of a distal element for an endoscope.
  • FIG. 29 is a drawing depicting a perspective view of an illustrative example of a distal element for an endoscope.
  • FIG. 30 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG 31 is a drawing depicting an end view of an illustrative example of an overmold for a distal element for an endoscope.
  • FIG. 32 is a drawing depicting an end view of an illustrative example of an overmold for a distal element for an endoscope.
  • FIG. 33 is a drawing depicting an end view of an illustrative example of an overmold for a distal element for an endoscope.
  • FIG. 34 is a drawing depicting a top perspective view of an illustrative example of a control element for an endoscope.
  • FIG. 35 is a drawing depicting a front perspective view of an illustrative example of a control element for an endoscope.
  • FIG. 36 is a drawing depicting a top perspective view of an illustrative example of a control element for an endoscope.
  • FIG. 37 is a drawing depicting a side perspective view of an illustrative example of a control element for an endoscope.
  • FIG. 38 is a drawing depicting a side perspective view of an illustrative example of a control element for an endoscope.
  • FIG. 39 is a block diagram depicting a system that incorporates an endoscope.
  • FIG. 40 is a block diagram depicting a system that incorporates an endoscope.
  • FIG. 41 is a screenshot of a setup display for the system.
  • FIG. 42 is a screenshot of a working display for the system.
  • FIG. 43 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG. 44 is a drawing depicting a side perspective view of an illustrative example of a distal element for an endoscope.
  • FIG. 45 is a drawing depicting a front view of an illustrative example of a distal element for an endoscope.
  • FIG. 46 is a drawing depicting a front view of an illustrative example of a distal element for an endoscope.
  • FIG. 47 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • FIG. 48 is a drawing depicting a perspective view of an illustrative example of a handlet for an endoscope.
  • Scopes having various functionality are increasingly important. There are many different types of scopes used for different purposes and often differing in size to accommodate the different elements required to meet the needs of the various. In the marketplace, there is a need for scopes which can accommodate the requirements of these various uses while maintaining dimensions that allow for ease of use and comfort level of patients. In particular, there is a need for small diameter scopes that are more easily accommodated by patients of varying size.
  • An embodiment of the invention includes a 3 mm to 5 mm flexible endoscope approximately 1 to 1.2 meter in length that allows high resolution, high definition, and clear optics of the nasal mucosa, pharynx and upper gastrointestinal tract with the head of a bronchoscope that allows four way tip deflection to allow use by individuals with varying hand sizes, an optional foot pedal to allow air/water insufflation for ease of use, a bright light source, an optional scope stiffening apparatus that will allow utilization in aerodigestive medicine (combined ENT- laryngoscopy, Pulmonary (bronchoscopy), and Gastroenterology (EGD) Procedures), an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to map and measure objects
  • an embodiment may include a miniaturized 3 mm to 4 mm flexible endoscope approximately 1 to 1.2 meter in length allow for high resolution, high definition, and clear optics of the nasal mucosa, pharynx and upper gastrointestinal tract with the small head of a pediatric bronchoscope that allows four way tip deflection to allow use by individuals with small hand sizes, an optional foot pedal to allow air/water insufflation for ease of use, a bright light source, an optional scope stiffening apparatus that will allow utilization in aerodigestive medicine (combined ENT -laryngoscopy, Pulmonary (bronchoscopy), and Gastroenterology (EGD) Procedures), an optional sensor array to allow the scope to sense in collaboration with its reporting systems distance from insertion, an optional sensor array to map and measure objects in the body cavity, a microphone to allow dictation into a reporting system and/or voice activation, and a 1.3 mm to 3.2 mm biopsy channel to assure utilization of currently available endoscopic tools in the mini
  • An endoscopic device may include a control element having ports, interface elements; and indicators.
  • the control element may be coupled to an elongated element that is also coupled to a distal element.
  • the elongated element may have a cross-sectional outer diameter of less than about 3.5 millimeter.
  • the elongated element may include a conduit, in particular, a non- collapsible conduit having a diameter in a range between about 1.0 to about 3.2 millimeters in diameter. In some instances, a non-collapsible conduit may be in range from about 2.8 to about 3.2 mm.
  • a non-collapsible conduit may be in a range from about 1.0 mm to 2.5 mm.
  • the distal element may include an illumination element, an optical element that will transmit images and/or video (via wires or wireless transmission) to an display (including video goggles) and a reporting system.
  • the reporting system may be voice activated and/or activated or controlled using interface elements.
  • An endoscopic device may have a non-collapsible conduit having a diameter in a range from about 1.3 to about 3.2 millimeters.
  • control element is optionally removable in some embodiments.
  • At least one of the interface elements of the control element is a four-way or greater distal element control mechanism.
  • a diameter of the non-collapsible conduit is in a range between about 1.3 to about 2.2 millimeter.
  • Optical elements for use in an embodiment have a field of view of at least eighty -five degrees and a depth of view of at least 5 mm. In some instances, the depth of view may exceed 100 mm.
  • a sound interface in the device and in particular, in the control element may be coupled to a computer system to allow for use of voice commands.
  • voice commands it may be possible to activate a dictation module during use of the device, so that the notes can be recorded.
  • voice activation may be used to activate any number of features of the device.
  • Sensors and/or elements may be configured to transmit data using wired and/or wireless connection. Sensors may be configured to interact with sensors and/or markers positioned on, in, or near a patient during use to determine a position or condition of the patient. For example, a distance and location sensor may interfaces with a computer system to note location and distance of a scope from the insertion point of the scope. A further sensor may measure a luminal diameter and surface features of a body cavity the scope is visualizing.
  • An endoscope system may include a removable control element having ports, interface elements, and indicators. Further, the endoscope may include an elongated element coupled to a control element having a cross-sectional outer diameter of less than four millimeter and including a conduit or channel having a diameter of at least 1.3 mm not greater than 2.2 mm. Further the a distal element includes an illumination element and an optical element. The system further includes a computer control unit having one or more device drivers. In addition, the system may include a computer and one or more display elements.
  • Audio elements such as microphones may be utilized to control functions of the system, including for example, the functioning of sensors. Further, audio elements may be used to facilitate auto-reporting, voice-activated commands, dictation, recording, and/or populating reports and/or databases.
  • An interface element may be configured to send data from at least one of the optical element, the audio element and the sensor array to a computer.
  • a conduit in the elongated element may be used as a feeding tube.
  • Unsedated laryngoscopy in pediatric otolaryngology and pediatric pulmonology has been performed in pediatric patients.
  • Curr Opin Pediatr 2008;20:266-71] Applicants hypothesized that TNE could be adapted to provide a safe and effective tool to monitor and sample the mucosa of children with EoE.
  • ETltra-slim flexible endoscopes were developed to create instruments that could be tolerated by children, while still allowing for the removal of adequate samples.
  • This scope design is unique in that it can be used in pediatric nasal endoscopy, pediatric nasal bronchoscopy, and pediatric laryngoscopy. This design differs from current adult nasal endoscopes in production in terms of numerous aspects including that that it is narrower, lighter, clearer, has foot controls, has smaller accessible hand controls to control the tip and be easier to maneuver. This scope will also have a stiffening capability and narrow tip to allow it to be used in aerodigestive medicine and other medical and surgical specialties.
  • the present disclosure documents the performance of TNE with biopsies using these ultra-slim flexible endoscopes to assess the esophageal, gastric, duodenal, tracheal, and bronchial mucosa in pediatric subjects with EoE.
  • the performance was assessed in part through the evaluation of parental and patient subject responses to TNE, the assessment of the ability to procure samples that would be adequate to monitor disease, monitoring adverse events, and recording procedure duration and charges generated. This assessment showed that unsedated transnasal endoscopy using the pediatric nasal endoscope disclosed herein offers an excellent alternative to sedated esophagogastroduodenoscopy.
  • TNE transnasal endoscopy
  • ESD sedated esophagogastroduodenoscopy
  • TNE with biopsies can be adapted as an effective tool to monitor the esophageal, gastric, and duodenal mucosa of children with eosinophilic esophagitis (EoE) or other conditions of the upper gastrointestinal tract with the proper tools and techniques. This technique can dramatically increase the safety and decrease cost in the care of children.
  • EoE eosinophilic esophagitis
  • the present embodiment provides an endoscope for assessment of the esophageal mucosa in children.
  • the endoscope can have a flexible endoscope shaft having a first end, a second end, a length of about 0.8 meters to about 1.3 meters (preferably about 0.9 meters to about 1.2 meters, more preferably about 1.0 meters to about 1.1 meters, or about 1.05 meters), an outer diameter of between about 3.0 mm to about 4.0 mm (preferably about 3.0 mm to about 5.0 mm, more preferably about 3.25 mm to about 4.0 mm, about 3.5 mm to about 4.0 mm, about 3.5 mm, or about 4.0 mm) and having an inner channel lumen of about 1.5 mm to about 2.5 mm in diameter (preferably about 1.75 mm to about 2.25 mm, or about 2.0 mm).
  • An embodiment of an endoscope includes an optional rounded tip.
  • a rounded tip may enhance the comfort of a patient during use.
  • the lumen extends substantially the length of the shaft, and will generally have an opening at the distal-most portion of the second end to allow a surgical instrument to partially exit the lumen for placement of the tool in proximity to a tissue of interest.
  • the lumen extending through the length of the shaft is non-collapsable.
  • the shaft can be configured to facilitate irrigation and suction at the second end of the shaft, such as by including connection to a source for an irrigation liquid and/or suction and passage across the shaft of the endoscope for the liquid and its return.
  • the endoscope according to the first aspect has a handle disposed at first end of the shaft.
  • the handle can have a single or dual control to adjust the disposition of the second end of the shaft.
  • the control enables four-way tip deflection of the second end of the shaft. This allows a user to direct the distal end of the shaft to facilitate visualization and sampling of desired tissues at the distal or second end.
  • the endoscope according to the first aspect has an image sensor at the second end of the shaft. The image sensor facilitates imaging of tissues at the distal end of the endoscope when the endoscope is inserted within a cavity of a subject.
  • the endoscope according to the first aspect has a light source disposed at the second end of the shaft to illuminate the area surrounding the distal end of the shaft.
  • the endoscope according to the first aspect can have a foot pedal or hand control to actuate suction or irrigation of the endoscope.
  • the control can be integral to the handle to actuate suction or irrigation of the endoscope.
  • the endoscope according to the first aspect can have a camera to facilitate visualization within the cavity of the subject.
  • the image sensor can be a charge-coupled device (CCD) sensor, a complementary metal-oxide-semiconductor (CMOS) sensor, N-type metal-oxide-semiconductor (NMOS) sensor or a high definition video chip.
  • CCD charge-coupled device
  • CMOS complementary metal-oxide-semiconductor
  • NMOS N-type metal-oxide-semiconductor
  • the endoscope according to the first aspect can have a scope shaft stiffening component.
  • the scope shaft stiffening component can be used to selectively reduce the flexibility of the scope shaft. In other words, a user can selectively alter the stiffness of the shaft during use to suit the particular stiffness needed to execute a procedure or direct the placement of the shaft.
  • the scope shaft stiffening component can adapted to facilitate the use of the endoscope in aerodigestive medicine.
  • the lumen can have an opening at the distal-most end of the second end of the shaft. This allows for the passage of instruments and for the irrigation and suction of biological tissues through the length of the shaft and their partial exit from the shaft.
  • the present embodiment provides an endoscope for transnasal endoscopy in children.
  • the endoscope according to the second aspect has a flexible endoscope shaft having a first end and a second end and has a diameter dimensioned for insertion into the nasal cavity of a child, a length of about 0.8 meters to 1.2 meters, and has an inner channel lumen configured to receive an elongate surgical instrument, the lumen extending substantially the length of the shaft.
  • the shaft is configured to facilitate irrigation and suction at the second end of the shaft.
  • the endoscope according to the second aspect has a handle disposed at first end of the shaft, the handle including a single or dual control to adjust the disposition of the second end of the shaft thereby enabling four-way tip deflection.
  • the endoscope according to the second aspect also has an image sensor at the second end of the shaft to facilitate imaging at the distal end of the endoscope when the endoscope is inserted within the nasal cavity of a subject.
  • the endoscope according to the second aspect has a light source disposed at the second end of the shaft to illuminate the area surrounding the distal end of the shaft.
  • the illumination source may come form an external source, such as a light source in the computer control unit, the control element, for example, a handle, and/or a control mechanism.
  • the light source may provide light through on or more optical fibers that extend to the tip.
  • a light source may be positioned in the shaft or elongated element and utilize optical fiber that extends to the tip or distal element.
  • the light source may be positioned in the distal element or tip of the endoscope.
  • the endoscope according to the second aspect can have a foot pedal or hand control to actuate suction or irrigation of the endoscope.
  • the control can be integral to the handle to actuate suction or irrigation of the endoscope.
  • the endoscope according to the second aspect can have a camera to facilitate visualization within the cavity of the subject.
  • the image sensor can be a charge-coupled device (CCD) sensor, a complementary metal-oxide-semiconductor (CMOS) sensor, N-type metal-oxide-semiconductor (NMOS) sensor or a high definition video chip.
  • CCD charge-coupled device
  • CMOS complementary metal-oxide-semiconductor
  • NMOS N-type metal-oxide-semiconductor
  • the endoscope according to the second aspect can have a scope shaft stiffening component.
  • the scope shaft stiffening component can adapted to facilitate the use of the endoscope in aerodigestive medicine.
  • the lumen can have an opening at the distal-most end of the second end of the shaft. This allows for the passage of instruments through the length of the shaft and their partial exit from the shaft.
  • the present embodiment provides a second endoscope for transnasal endoscopy in children.
  • the endoscope according to the third aspect has a flexible endoscope shaft having a first end, a second end, a shaft diameter dimensioned for insertion into the nasal cavity of a child, a shaft length adapted to facilitate insertion of the shaft through the nasal cavity to the esophageal mucosa of a child, and an inner channel lumen configured to receive an elongate surgical instrument.
  • the lumen extends substantially the length of the shaft.
  • the shaft is further configured to facilitate irrigation and suction at the second end of the shaft.
  • the endoscope according to the third aspect has a handle disposed at first end of the shaft.
  • the handle has a single or dual control to adjust the disposition of the second end of the shaft thereby enabling four-way tip deflection.
  • the endoscope according to the third aspect also has an image sensor at the second end of the shaft to facilitate imaging at the distal end of the endoscope when the endoscope is inserted within the nasal cavity of a subject.
  • the endoscope according to the third aspect has a light source disposed at the second end of the shaft to illuminate the area surrounding the distal end of the shaft.
  • the endoscope according to the third aspect can have a foot pedal or hand control to actuate suction or irrigation of the endoscope.
  • the control can be integral to the handle to actuate suction or irrigation of the endoscope.
  • the endoscope according to the third aspect can have a camera to facilitate visualization within the cavity of the subject.
  • the image sensor can be a charge-coupled device (CCD) sensor, a complementary metal-oxide-semiconductor (CMOS) sensor, N-type metal-oxide-semiconductor (NMOS) sensor or a high definition video chip.
  • the image sensor may transmit data via wires, cables and/or wirelessly to a display. For example, in some instances data is transmitted to a video monitor. In an embodiment, data from the image sensor is transmitted to a display that can be worn by the operator, for example, a video goggle system in use by the operator.
  • the endoscope according to the third aspect can have a scope shaft stiffening component.
  • the scope shaft stiffening component can adapted to facilitate the use of the endoscope in aerodigestive medicine.
  • the lumen can have an opening at the distal-most end of the second end of the shaft. This allows for the passage of instruments through the length of the shaft and their partial exit from the shaft.
  • An advantageous embodiment of the endoscope includes an audio device, such as a microphone.
  • an audio device may be positioned in the endoscope, for example, in a control element, for example a handle and/or a control mechanism.
  • the audio device may be positioned in an external component, for example, a computer control unit and/or elements that are worn by the operator, for example, wearable electronics, such as a wearable display, for example, a video goggle system and/or wrist display, a headset microphone, a backpack mounted microphone or the like.
  • the audio device for example, one or more microphones may be integrally tied to a reporting system such that voice activation and/or voice dictation are allowed.
  • Some embodiments of the endoscope and/or system may include a sensor array to allow the scope to report the distance traveled in the body cavity from a point of insertion.
  • An embodiment of the endoscope may include a sensor array to measure various properties of a luminal body. For example, the sensor array may provide dimensional measurements of any structures found within a luminal body cavity or the luminal body itself.
  • Un sedated TNE is an established technique in a number of pediatric and adult sub specialties, but it has not been used by pediatric gastroenterologists.
  • Applicants are particularly encouraged by their findings for several reasons. First, there was great interest in this procedure amongst patients and parents. Applicants only needed to screen 22 subjects to enroll the 21 subjects reported here. This is likely explained by the fact that the EoE patient population represents a very engaged, experienced, and educated population that is readily seeking alternative methods. Applicants are highly confident that this is a technically feasible procedure, and are further encouraged by its overall rapid success that was facilitated by a multidisciplinary pediatric team dedicated to the care of children with aerodigestive diseases and EoE. Applicants’ study provides strong support for larger studies to validate this approach that will provide novel insights into the natural history of EoE and significantly improve the lives of children with EoE in a safer, cost effective, and efficacious manner.
  • the time at CHCO for a standard EGD is 3 hours compared to 60-90 minutes for the TNE, a time that included not only the TNE but also research protocol documentation.
  • This 3-hour procedure center time for EGD usually includes check in, pre-operative evaluation by nursing, gastroenterology, and anesthesia, the procedure itself, recovery, and discharge instructions.
  • the 60-90 minute time for TNE in clinic included research documentation, pre-procedural documentation, the procedure itself, and discharge instructions. Most of these improvements in time reduction and increased satisfaction, noted above, are related to the effects of eliminating anesthesia or sedation for TNE. Not only does this practice seem to improve satisfaction of patients and parents, but there is also a significant likelihood it decreases the risk of adverse medication reactions, aspiration, and possible effects on the developing pediatric brain.
  • the third positive outcome of Applicants’ study relates to the integrity of the mucosal sample.
  • Applicants found that the epithelial surface area needed for eosinophil count evaluation was not significantly different from the standard EGD 2.8 mm biopsy forceps compared to either of the TNE 2 mm or 1.2 mm biopsy forceps. This finding provides a high level of confidence that the sample procured at the time of TNE will have the same surface area compared to that obtained with the gold standard EGD biopsy forceps. The 2 mm forceps were also able to procure lamina intestinal.
  • TNE financial benefits of TNE include the fact that TNE incurred fewer charges and required less time away from work and school when compared to a standard sedated pediatric EGD.
  • the project demonstrated a significant 60.1% drop in charges.
  • the majority of this reduction in cost is related to the lack of anesthetic/anesthesiologist during TNE. The significance of this cannot be understated. For example, if Applicants’ institution were to perform 100 sedated EGD’ s per year for EoE at a hypothetical average, non-insurance adjusted charge of $9,390 dollars per general anesthesia provided endoscopy encounter, this would accumulate $939,000 total charges per year for EoE.
  • TNE in pediatric gastroenterology for the evaluation of pediatric EoE is safe, preferred by patients and parents alike, and has the potential to dramatically reduce costs.
  • TNE would be measured as a highly effective practice in pediatric EoE management per Berwick’s description of the triple aim: the pursuit of improved experience of care, the health of populations should be improved, and the cost of per capita healthcare should be decreased.
  • Berwick DM Nolan TW, Whittington J. Health Aff ( Millwood) 2008;27:759-69
  • TNE use should be highly considered as an alternative to standard sedated EGD or esophagoscopy for the follow up evaluation of pediatric EoE.
  • the technique will continue to be refined and improved, offering more opportunities for its use in monitoring response to therapeutics, obtaining follow-up evaluations, and performing research in EoE.
  • the pediatric nasal endoscope 10 was developed to perform TNE in children.
  • the pediatric nasal endoscope 10 includes a flexible endoscope shaft 20 constructed from medical-grade slippery (such as a hydrophobic) material with a slick coating having a length of about 1.05 meters and a width of about 3.5 mm.
  • the flexible endoscope shaft 20 has a biopsy channel 30 running the length of the endoscope shaft and is adapted to slidingly receive a pediatric nasal endoscope biopsy forceps 70 (See FIG. 3) within the lumen of the channel or allow suction or irrigation.
  • the distal end 40 of the flexible endoscope shaft 20 is rounded and can be flat or if the end user wishes designed to be terminated with an optional, removable soft silicone tip 41
  • the distal end 40 of the flexible endoscope shaft 20 also includes a high lumen LED 42 to provide light at the tip and a high-resolution video capture device 44 to capture images or video in the region of the distal end 40 of the flexible endoscope 20
  • the proximal end 50 of the flexible endoscope shaft 20 can include a single 4-way tip deflection control lever 52 to control the displacement of the endoscope’s tip, a button 54 to actuate photo or video and/or autotranscription features associated with a reporting system capabilities of the endoscope, a hand control 56 to operate air and/or water suction, a line out 57 to a imaging system such as a computer monitor, an optional scope stiffening device 58 to allow its use in aerodigestive medicine.
  • a foot pedal 60 can also be coupled to the endoscope to activate and control water flow and air
  • the flexible endoscope shaft 20 has a biopsy channel 30 running the length of the endoscope and is adapted to slidingly receive a pediatric nasal endoscope biopsy forceps 70 (See FIG. 5) within the lumen of the channel 30
  • a pediatric nasal endoscope biopsy forceps 70 See FIG. 5
  • FIG. 5 an exemplary pediatric nasal endoscope biopsy forceps 70 is illustrated.
  • the pediatric nasal endoscope biopsy forceps 70 has a length of about 1.2 meters, which is slightly longer than the length of the biopsy channel 30, a width of about 2 mm, and opposing ends forming a distal end 71 and a proximal end 72.
  • the distal end 71 includes a cupped and spiked tip with an opening of about 2.8 mm to 5 mm when fully open.
  • the proximal end 72 includes an actuator to open and close the tip at the distal end 71 of the forceps 70.
  • TNE transnasal endoscopy/esophagoscopy
  • Endoscopic devices elements thereof, and/or systems utilizing endoscopes are described herein. Endoscopes may be used in combination with other elements in a system to enhance the capabilities of the scope and/or increase a number of uses for which the scope may be used.
  • endoscope 62 includes distal element 63, elongated element 64 and control element 65.
  • An endoscope may be coupled to external supplies and/or reservoirs of materials.
  • endoscope 62 is coupled to air supply 66, liquid supply 67, and suction 68.
  • endoscope 62 includes interface elements 69, 73.
  • Endoscope 62 is coupled to computer control unit 75 and computer 76.
  • the control element may include a port or a number of ports which are used to provide and/or removal materials to/from a target area.
  • ports may be used to supply and/or remove fluids to/from a target area, such as water, air, and/or medications in specific measured amounts.
  • an interface element may be configured to deliver one or more pre-determined amounts of water, air and/or medicine during use by the operator based on a procedure, protocol, patient needs (for example, patient size) and/or preferences of the operator.
  • an interface element may be configured to remove predetermined amounts of fluids.
  • suction may connected to a port in order to provide suction to a target area.
  • Ports may include coupling structures to couple various delivery systems to the control element.
  • control elements may include interface elements.
  • an interface element may be used to control the positioning and/or functions of distal element, a portion of the elongated element, the function of devices and/or sensors positioned along the elongated element and/or the distal element.
  • an interface element may be used to determine a distance from an insertion point and/or measure luminal body findings. For example, determining a diameter of lumen, such as an esophagus or bronchus, and/or measuring the size a lumen and/or findings therein, such as a gastric polyp or ulcer.
  • interface elements may control aspects of the optical system.
  • interface elements may control image capture, video, and/or audio recording.
  • interface element 69 may control the imaging element.
  • an interface element may be programmed such that different user interactions may be recognized by the system as different commands.
  • interface element 69 may be programmed to capture an image upon a momentary touch.
  • interface element 69 may be programmed to start and/or end video capture when interface element is pressed and held.
  • interface element 73 may be programed such that a touch, for example, a momentary touch, may provide an instruction that the device will auto-populate a section of a report, while a press and hold motion will instruct the device to record audio.
  • the auto-populate feature would enable audio to be transmitted from the microphone in the control element to a reporting system where it would be transcribed into a report system automatically.
  • an auto-populate feature may be used to populate any portion of form with transcribed audio data, audio files, video files, metrics measured by sensors, in particular, dimensions, position of the endoscope, and/or other physiological conditions within a body or portion of the body being viewed.
  • a control element may include a steering mechanism.
  • Fig. 6 depicts user interface 74 which may be used as a steering mechanism.
  • the steering mechanism will be a four-way mechanism.
  • the steering mechanism may be constructed along the lines of a joystick and/or roller ball to allow for single hand manipulation and steering.
  • the control element may have a housing constructed using standard methods known in the art, as well as newly developed technologies.
  • the control element may have a housing that is constructed using three dimensional printing.
  • Figs. 7A-B depict an exploded partial cut-away views of endoscopes 77.
  • distal element 63 is positioned proximate steering collar 78 which is positioned proximate to elongated element 64.
  • a portion of imaging element 79 extends from the distal element while a portion is positioned in conduit 22 of distal element 63 and extends through steering collar 78 and into conduit 24 of the elongated element 77
  • the distal element of the endoscope may have a rounded end, a flat end, and/or a combination.
  • an end of the distal element may include a soft tip, for example, a soft silicone tip.
  • Distal elements may be constructed from one or more materials including, but not limited to plastics such as acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polycarbonate-acrylonitrile butadiene styrene (PC/ ABS), high density polyethylene (HDPE), polyamide (PA), poly ether ether ketone (PEEK), polypropylene (PP), and/or polyvinyl chloride (PVC), metals such as aluminum, stainless steel, carbon steel, titanium, and/or magnesium and/or combinations thereof.
  • ABS acrylonitrile butadiene styrene
  • PC polycarbonate
  • PC/ ABS polycarbonate-acrylonitrile butadiene styrene
  • HDPE high density polyethylene
  • PA polyamide
  • PEEK poly ether ether ketone
  • PP polypropylene
  • PVC polyvinyl chloride
  • metals such as aluminum, stainless steel, carbon steel, titanium, and/or magnesium and/or combinations
  • Elongated elements 77 of Figs. 7A-B include steering collar 78, extruded element 26, tubular element 28 and shrink element 29. As is shown in Figs. 7A-B, extruded element is surrounded at least in part by tubular element 28, which is in turn surrounded by the shrink element 29. As can be seen in both Figs. 7A-B, steering guides 25 are positioned within groove 27 on the extruded element 26. Fig. 7A depicts steering guides connected to the steering collar 78 at groove 27.
  • an end of distal element 80 shows multiple conduits 82, 83, 84.
  • conduits 82, 83, 84 may be used to house devices and/or portions thereof that are necessary for the functioning of the endoscope.
  • one or more of the conduits may be used to house optical fiber.
  • the conduits may extend from the distal end to the proximal end of the elongated element.
  • one or more of the conduits may extent from a middle of the elongated element to an end.
  • Distal element 80 includes channel 85. As shown in Fig. 8, channel 85 may be partially open.
  • Fig. 9 depicts a cross-sectional view of Fig. 8 along line A-A.
  • distal element 80 includes conduit 82 and channel 85 both of which extend along the length of distal element 80.
  • a geometry of conduit 82 may vary along a length of the distal element. For example, an inner diameter can be varied.
  • An outer diameter of distal element may also vary. For example, as can be seen in Fig. 9 such that it may be fitted to an elongated element. As can be seen in Fig. 9, a face of the distal element 80 is shaped.
  • Fig. 10 depicts a perspective view of an embodiment of a distal element having a single conduit 102 and an open channel 104. Further, it can be seen in Fig. 10, that the outer diameter of the distal element 100 varies its length. Coupling section 106 has a smaller diameter than the rest of distal element. The coupling section may be constructed in a manner such that it couples to an elongated element.
  • Fig. 11 depicts an end of distal element 110 having multiple conduits 112, 114. Conduit 114 is cut using a swept cut path.
  • Fig. 12 depicts a cross-sectional view of distal element 110. As can be seen in Fig. 12, a path of conduit 114 varies along a length of the distal element. In particular, the path of conduit 114 moves from an edge of the distal element 1 10 toward a middle of the distal element 110. A geometry of conduit 112 changes along a length of distal element 110. As can be seen in Fig. 12, a section of conduit 112 has a rectangular geometry and a further section of conduit 112 has a substantially circular geometry. As shown in Fig. 12, an outer diameter of the distal element 110 varies along the length of the distal element.
  • Fig. 13 depicts a perspective view of distal element 110 shown in Figs. 11, 12, 14.
  • conduit 112 includes cut-outs 132. Cut-outs may conform a shape of devices, tubing, and/or other elements. In some instances, cut-outs may help to elements placed within a conduit.
  • an outer diameter and geometry is varied along the length of the distal element 110. Cut-out 134 is positioned on an outer surface of distal element 110. In some embodiments, cut-out 134 may be designed to couple with an elongated element.
  • An embodiment may include a cut-out designed to house a device such as a sensor, imaging element, light, or the like, cable, wire, and/or fiber optic element.
  • Fig. 14 depicts a top perspective view of distal element 110. From this view, the variation of the geometry along the length of the distal element is visible.
  • distal element 150 includes multiple conduits 152, 154, 156 and channels 156.
  • Conduit 152 has a larger diameter that the remaining conduits. Conduit 152 may act as a working conduit.
  • Channels 156 are partially open. In some embodiments, channels that are partially open may house a camera sensor and/or optical fiber.
  • Figs. 16-19 depict various views of a distal element constructed using sliced layers.
  • Sliced layer construction may allow for more complicated geometries. Processing limitations of standard construction methods may limit design given size ranges of these elements, thus, it may be desirable to used sliced layer construction and/or additive manufacturing, such as three dimensional printing. For example, a sliced layer construction process may enable the use of a swept cut path in a conduit of the distal element.
  • Figs. 16-17 the sliced layers allow for changing an elevation of conduit 162 along the length of the distal element.
  • Conduit 164 varies in geometry along a length of the distal element 160.
  • Fig. 18 depicts a perspective view of distal element 160.
  • Distal element includes conduits 162, 164, as well as channels 166.
  • distal element 202 is constructed from multiple sections. Use of multiple sections in the distal element may inhibit undercuts.
  • Distal element 202 includes conduit 204, as well as open channel 206.
  • Fig. 20 showing an end view of distal element 202 which includes channels 208 for lighting elements such as a lightpipe, fiber optic elements, or clear epoxy.
  • Fig. 21 depicts a cross-sectional view of distal element 202 shown in Fig. 20 along line A-A.
  • Light source 210 is positioned proximate conduit 204 such that the light source provides light to a target area through channels 208.
  • Light source may include, but is not limited to Xenon lights, organic light-emitting diode (“OLED”) lights, light-emitting diode (“LED”) lights, for example, high lumen LEDs.
  • Figs. 22-23 show channels 222 positioned on an outer surface of the distal element 202.
  • Fig. 24 depicts an end view of distal element 240 constructed from flexible member 242 and rigid body 244 which define conduit 245.
  • Conduit 248 is depicted clearly in Fig. 25 which shows a perspective view of the distal element.
  • a side view of the distal element 240 is shown in Fig. 26.
  • Fig. 27 illustrates an end view of a distal element having an egg shaped face.
  • Distal element 270 includes conduits 272, 274, 276.
  • a cross-sectional view of Fig. 27 along line A-A is shown in Fig. 28.
  • Conduits 272, 276 are both shown having varying diameters along the length of the distal element.
  • Conduit 272 may be a working conduit or working channel.
  • conduit 276 may house an optical sensor.
  • Figs. 29-30 depict a perspective view and a top view of distal element 270, respectively. Channels 292, 294 are positioned on an outer surface of distal element 270. Fig. 30 clearly depicts the varying outer diameter along the length of the distal element.
  • Overmold drawings reflect a tool necessary to create the distal element.
  • Various configurations were constructed that corresponded to the geometries of the distal element as can be seen in Figs. 31-33.
  • distal element 80 includes conduit 82 and channel 85 both of which extend along the length of distal element 80.
  • a geometry of conduit 82 may vary along a length of the distal element.
  • an inner diameter can be varied.
  • An outer diameter of distal element may also vary.
  • a face of the distal element 80 is shaped.
  • the scope may include a distal element having openings for additional devices or elements.
  • the distal element may include openings for an illumination element, such as a fiber optic cable, light, and/or light source, and/or an optical element, such as a camera.
  • An optical element may include a device having a field of view of greater than 60°. In some embodiments, the field of view of the optical element may be greater than 85° or as high as 150 degrees. Further, the depth of field may be as small as 5mm greater than 15 mm. In some instances, the depth of field may be greater than 19 mm.
  • An optical element such as a camera, for example, a high definition camera or videoscope may include devices such as, but not limited to miniature videoscopes.
  • the distal element may also include openings which may allow for manipulation at a predetermined location, delivery of materials, such as air, liquid, medicines, devices, etc., and/or retrieval of materials, such as tissue, devices, fluids.
  • the distal element may include an opening which allows for use of suction at a predetermined location and/or a target area.
  • Elongated elements may couple to both the distal element and the control element.
  • a length of length of an elongated element may be in a range between 0.5 to 1.5 meters.
  • an elongated element may have a length in a range from about 0.8 to 1.2 meters in some embodiments.
  • An outer diameter of an elongated element may be less than about 4.5 millimeter.
  • the outer diameter of an elongated member may be less than 4.0 millimeter.
  • an elongated element may have an outer diameter of less than about 3.5 millimeters in an embodiment.
  • a further illustrative example includes an elongated member and/or shaft having a diameter in a range between 4 mm to 5 mm.
  • a channel extending through the elongated member or shaft may have a diameter in a range from about 2.5 to 3.0 mm.
  • an elongated member of a scope may have an outer diameter in a range between 4.3 to 4.5 mm and a channel or conduit having a diameter in a range from about 2.8 to 3.0 mm.
  • a scope may be utilized for applications where the openings may be larger or the scope requires additional room for additional elements. This may be particularly true for applications involving adults and/or training on devices, such as simulators.
  • a stiffness of the elongated element may vary along its length. At least a portion of the length may be flexible.
  • variable stiffness along the length of the elongated element may be created using a stainless steel tube that is laser cut with a variable interrupted spiral pattern. The more cuts, the more material is removed and the more flexible the shaft becomes.
  • an elongated element may be designed to have a stiffer area proximate the control element such that torque cam be transferred, while being flexible proximate the distal element such that tight bends can be negotiated and/or patient comfort improved.
  • the elongated element may include a braided metal section to provide variable stiffness.
  • a length of a flexible portion of the elongated element may be in a range from about 30 to about 50 millimeters.
  • a flexible portion of an elongated member may have a length in range from about35 to 45 millimeters.
  • the length of the flexible portion of the elongated element may be approximately 40 mm.
  • An elongated element may include one or more conduits.
  • the conduits may have various configurations.
  • the conduits may be coaxial, positioned proximate each other, and/or positioned on opposite sides of the cross-section of the elongated element.
  • Conduits may include one or more lumen.
  • a conduit may be a multi -lumen.
  • Conduits may act as a housing for elements inserted into the elongated element.
  • the elongated element may have one or more conduits configured to receive devices and/or sensors to provide access to a target area.
  • conduits may provide a path for materials to reach the distal element and/or a target area. Further, a conduit may be used to transport materials from the target area to control element or, in some cases, to a position external to the control element.
  • Elongated element 62 includes conduit 24 running the length of the endoscope elongated element.
  • the conduit may slidingly receive instruments, such as a nasal endoscope biopsy forceps 70 (See FIG. 3) within the lumen of the conduit and/or allow suction or irrigation.
  • a working conduit in the elongated element may have an inner diameter of greater than about 2.0 millimeters. Further, the inner diameter of working conduit may be greater than about 2.1 millimeters in some embodiments.
  • At least one conduit through the elongated element may have an inner diameter of greater than about 1.3 millimeters. Some embodiments may include conduits having an inner diameter of about 1.4 millimeters or greater.
  • a sensor array may be used to take measurements throughout a procedure.
  • a sensor array may make distance measurements, for example, the distance that an endoscope has traveled in the body, luminal measurements, such as diameters, lengths, and/or volumes, quantitative changes, physiological measurements within the body, such as temperature, pulse oximetry measurements, and/or etc.
  • An endoscope may include an elongated element having a flexible section.
  • This flexible section of the elongated element may be constructed from a medical-grade material.
  • a hydrophobic material may be used. Hydrophobic materials may create a slippery surface which allows the device to be inserted with more ease and/or less discomfort to the patient.
  • Elongated member 62 of endoscope also includes imaging element 79 and illumination element 36.
  • imaging element 79 For example, a high lumen LED may be used to provide light and a high-resolution video capture device may be used to capture images and/or video in the region of the distal end of the endoscope.
  • control elements may include any combination of ports, interface elements, and/or indicators.
  • an interface element may include a steering element which may control the movement and/or displacement of the distal element and/or optical element of the endoscope.
  • the degrees of deflection from the normal position for the distal element may be greater than 90° in at least one direction.
  • the degrees of deflection from the normal position for the distal element may be 90° in three directions and greater than 90° in a fourth direction. Deflection may be achieved by pulling on steering guides, for example, steering wires.
  • Interface elements may be positioned on a control element to provide for ease of use of the operator.
  • interface elements may be positioned along a top surface, a side surface, and/or an underside of the control element.
  • An embodiment of an interface element may act in a joystick-like manner to control movement of the distal element.
  • Fig. 34 depicts a control element 3602 which is designed such that it conforms to the shape of a hand.
  • Interface element 3604 is controlled in a manner similar to a roller ball for ease of use.
  • interface elements 3606, 3608, may be control audio recording and image capture, respectively.
  • interface element 3606 may control audio recording and transcription.
  • These interface elements may have multiple settings. For example, a quick press may take an image or record a predetermined amount of audio, while pressing and holding these elements may activate video recording or extended audio recording.
  • the interface elements may be programmed to initiate auto-reporting data to one or more reports, databases, or processors. Data may include, for example, audio, visual, positioning, and temporal data, as well as physical and physiological measurements.
  • the functionality of the interface elements may be programmable by a user for ease of use.
  • the functionality of the interface elements may be defined by a use of the device. For example, when then endoscope device is used to monitor a feeding tube the needs may be different from when the endoscope device is used to conduct a TNE.
  • Fig. 35 depicts a front perspective view of control element 3702 which conforms to the shape of a hand. As can be seen in Fig. 35, ports 3704, 3706 may be positioned such that they do not interfere with the interface elements and the user’ s ability to control aspects of the endoscope.
  • port 3704 serves as a connection point for suction while port 3706 allows for a connection of fluids, in particular, air and/or water.
  • Port 3708 provides access to a conduit and/or channel that runs through elongated element 3710.
  • the control element may include multiple ports. At least one port may provide access to a a channel and/or conduit within the elongate member.
  • An insertion element for example an instrument may be inserted into a conduit of the elongated element using a port. Further, an instrument may be coupled to a control element at a portwhich provides access to a conduit and/or channel within elongated element.
  • An insertion element may include, but is not limited to an instrument, such as forceps, in particular, biopsy forceps, a feeding tube, a cable for sensors, sensors, accessory, illumination elements and/or optical elements. Further, interface elements may be positioned on a control element such that it provides easy maneuverability of the distal element.
  • control element after positioning of an instrument within the elongated element, the control element may be removed. Wires and/or connectors to various elements, for example, audio and imaging elements, sensors, and the like may be remain so that these elements can be used.
  • Fig. 36 depicts a rear perspective view of a further embodiment of a control element.
  • Control element 3902 includes interface elements 3904, 3906, 3908, 3910, 3912.
  • Port 3914 connects to line 3916 which may connect to a computer control element, a display, and/or a computer.
  • port 3914 is used to provide suction, air, and/or water, as well as house electronics.
  • Interface element 3906 may be used to actuate photo or video capabilities of the endoscope, while interface 3904 may be used to control audio input.
  • Interface elements 3910, 3912 may be used to control movement of the distal element, for example, via a steering collar (shown in Figs. 7A-B) in part.
  • Interface element 3908 controls an amount and/or duration of fluid provided to a target area via the endoscope.
  • interface element 3908 may be programmed to deliver predetermined amount of fluid over a predetermined time frame. These settings may be controlled by a user and/or by protocols designed for each use of the endoscope. In particular, a short twist of interface element 3908 may deliver 5 mL bursts of water to the target area.
  • Fig. 37 depicts a side view of control element and illustrates the ergonomic design of the control element.
  • Port 4006 provides a connector for suction, so that suction can be provided to a target area.
  • Port 4004 provides a connection for fluids which may be delivered to a target area. An amount of fluid and/or type of fluid may be controlled using the interface element 4012.
  • Interface element 4014 controls the positioning of the distal element.
  • Port 4008 provides access to the target area via a conduit running through the elongated element for insertion element 4010.
  • a scope stiffening element to allow use of the endoscope in aerodigestive medicine.
  • a wire may be used as a stiffening element in the elongated element.
  • Additional interface elements may be used to control various aspects of the device.
  • foot pedals may be used to activate and control fluid flows and/or suction, control imaging devices and/or audio devices.
  • Input devices capable of providing information to the various systems may include interface elements, for example, buttons, joystics, tracker balls, foot pedals, virtual reality devices, goggles, glasses, and the like, sensors, imaging elements, audio elements, and/or any device configured to report a value.
  • an interface element may be programmed to interact with a specific a behavior of the operator to achieve a desired outcome.
  • it may be possible to customize the inputs based on the needs and/or desires of a user and/or a use. For example, some users may prefer a specific configuration of interface elements that combine input from one or both hand and/or one or both feet. Further, some protocols may require specific movements from a user that may make it desirable to alter the inputs so that the user has an increased ability to use their hands for other purposes.
  • the elongated element 4107 has a conduit running the length of the endoscope and is adapted to slidingly receive an inserted element, such as biopsy forceps, through port 4106 and into a lumen of the conduit.
  • Control element 4102 also includes port 4110 for connecting to the computer control unit, a computer and/or a display. Ports 4112, 4114 may be configured to deliver fluids and/or such to a target area via the endoscope.
  • Fig. 38 depicts a side view of a further embodiment of a control element 4202.
  • Interface elements 4204 may be used to control what is occurring at a target area.
  • Ports 4206, 4208, 4210 may be used to provide inputs and/or remove materials to a target areas.
  • control element 4302 may be connected to a computer control element 4304 via cables 4306. Further, the control element may be connected to a computer and/or a display.
  • Fig. 39 depicts positions for a light source for use with the endoscope.
  • light source 4308 may be positioned proximate and/or in distal element 4310.
  • a light source 4312 may also be positioned in control element 4302.
  • light source 4316 may be positioned on computer control unit 4304. Regardless of the position light may be provided to an illumination element positioned on distal element 4310 using optical fiber.
  • the computer control element may be designed to sit on a bench.
  • a size of the computer control element may be less than thirty centimeters by 16 centimeters by 10 centimeters.
  • the computer control element may be designed to be portable for easy transport.
  • endoscope 4402 may be connected to computer control element
  • optical fiber 4406 may connect light source 4410 in computer control element 4404 with illumination elements positioned on the scope.
  • Images captured on the imaging element may be displayed using a computer connected to the computer control element.
  • Fig. 40 depicts an illustrative example of a system including endoscope 4402 coupled to a computer control unit 4404 that includes multiple drivers 4412, 4414
  • an optical element controller 4412 is positioned within the computer control element 4404. Data may be transmitted from the optical element controller 4412 to computer 4416 and/or display 4418.
  • processor 4414 may alter data from the optical element controller prior to providing it to computer 4414.
  • a screen connected to the computer will be controlled by software such that information and/or images related to a patient and/or procedure are displayed on the screen.
  • software may have a setup form 4500 which shows up on a display. Fields on the setup form may vary according to the requirements of the physician, hospital, and/or procedure.
  • Images, forms and/or reports may be generated by the computer from one or more inputs from a program, a user, an audio element, an imaging element, and/or sensors.
  • the computer may follow a predetermined algorithm that displays various images depending on the type of procedure performed. For example, Fig. 42 depicts a display for use during a procedure which shows live stream video 4600, a static image 4602 and/or report 4604 These fields may be determined by an end-user, such as a physician, a hospital, or the like.
  • the system may be designed to auto-report. In some instances, this may occur based on a predetermined time interval, movement interval and/or event. Further, auto-reporting may be controlled by an end-user.
  • the devices and/or systems described herein may be used to deliver medications to a target area, remove tissue from a target area, for example to conduct a biopsy, to promote cessation of bleeding/cautery, to remove a foreign body, to collect samples from a target area, in particular bodily fluids, study target areas, in particular the gastrointestinal tract, to evaluate existing and/or potential disease by examining tissues, in particular, pharynx/larynx/esophagus/stomach/small intestine tissues, to diagnose disease or conditions, for example, celiac disease, infection, etc., and/or to manage airways, among others.
  • the present invention also contemplates the use of the herein disclosed endoscope for measuring an airway, dilation of an airway, gastrointestinal (GI) tract and/or throat as well as placement of enteral feeding tubes and body devices in an airway and GI tract.
  • GI gastrointestinal
  • the treatment of an airway with the treatment device disclosed in US Patent No. 9,358,024 involves placing an endoscope. The treatment device is then inserted through or next to the endoscope while visualizing the airways.
  • the visualization system may be built directly into the treatment device using fiber optic imaging and lenses or a CCD and lens arranged at the distal portion of the treatment device.
  • the treatment device may also be positioned using radiographic visualization such as fluoroscopy or other external visualization means.
  • the treatment device which has been positioned with a distal end within an airway to be treated is energized so that energy is applied to the tissue of the airway walls in a desired pattern and intensity.
  • the distal end of the treatment device may be moved through the airway in a uniform painting like motion to expose the entire length of an airway to be treated to the energy.
  • the treatment device may be passed axially along the airway one or more times to achieve adequate treatment.
  • the "painting-like" motion used to exposed the entire length of an airway to the energy may be performed by moving the entire treatment device from the proximal end either manually or by motor. Alternatively, segments, stripes, rings or other treatment patterns may be used.
  • Sensor elements disposed in the sheath body disclosed in US Patent No. 8,926,501 may be configured so as to provide sensing contact with a space exterior to the sheath, such as an airway between the sheath and a patient's throat or other body orifice, a blood vessel in a vascular implementations, or other body orifices such as those in the digestive system or excretory system.
  • sensors may be disposed in the body so as to be in contact with a space interior to the sheath, such as a space between the interior surface of the sheath and an inserted endoscope.
  • Sensors may be disposed in the body by attachment to the body on the interior or exterior, such as by use of adhesives or other attachment materials, by molding or forming into the body, or by other attachment or forming methods known or developed in the art.
  • Physical conditions of interest may include pressure, temperature, flow rate (based on, for example, flow of a gas such as air through an airway or fluid, such as blood, through a flow channel such as an artery or vein), pH, cross-sectional distance measurements (such as measurement of cross-sectional areas of a gas or liquid flow channel, such as the nasal passages or throat), acoustic information (audible sounds or other acoustic information), blood pressure, pulse, and the like.
  • a gas such as air through an airway or fluid, such as blood, through a flow channel such as an artery or vein
  • pH pH
  • cross-sectional distance measurements such as measurement of cross-sectional areas of a gas or liquid flow channel, such as the nasal passages or throat
  • acoustic information audible sounds or other acoustic information
  • blood pressure pulse, and the like.
  • a sensor element comprises a pressure sensor, configured to measure pressure at or near a location being imaged by the endoscope.
  • a pressure sensor may also include one or more additional sensor elements. For example, in one
  • a sensor element comprises a pressure sensor and temperature sensor, such as a MEMS based circuit like the SCP1000 device manufactured by VTI Technologies, which is configured to measure both pressure and temperature at or near the location being imaged.
  • a MEMS based circuit like the SCP1000 device manufactured by VTI Technologies, which is configured to measure both pressure and temperature at or near the location being imaged.
  • Other similar or equivalent devices known or developed in the art may also be used in various implementations.
  • the present invention also encompasses a method for determining properties of a body lumen at different states with an endoscopic instrument as disclosed in US Patent No. 8,696,547.
  • the method of the‘547 patent involves providing a computer having a processor configured to: acquire a first set of 3D image data of a body lumen at a first lumen state; acquire a second set of 3D image data of the body lumen at a second lumen state, the body lumen having a different shape in the second lumen state than in the first lumen state; determine from the first set of previously acquired 3D image data a first property at each location along the body lumen; determine from the second set of previously acquired 3D image data the first property at each location along the body lumen; register the first property at the first lumen state to the first property at the second lumen state at each location along the body lumen, thereby mapping the first property at the first lumen state and the first property at the second lumen state for each location along the body lumen; estimate an endoscopic instrument position of the endoscopic instrument
  • the present invention also encompasses a method for continuous guidance of endoscopy during a live procedure as disclosed in US Patent No. 8,672,836.
  • the method of the ‘836 patent involves the steps of: a) providing a precomputed data-set based on 3D image data, the data-set including reference information representative of a predefined route through a body organ to a final destination, the reference information including virtual endoscopic (VE) image data representing one or more of the following: 3D organ surfaces, 3D routes through an organ system, and 3D regions of interest (ROIs); b) displaying a plurality of live real endoscopic (RE) images as an operator maneuvers an endoscope within the body organ; c) presenting information, corresponding to an initial reference location along the predefined route, which enables an endoscope operator to move the endoscope toward the reference location; d) invoking a registration/tracking algorithm that registers the VE image data to one or more of the RE images and continuously maintains the registration as the endoscope is
  • the endoscope of the present invention also contemplates a method of collecting and/or sampling body fluids.
  • a body fluid collection device disclosed in EiS Patent No. 9,713,461 comprises a longitudinal member having a lumen formed along a longitudinal axis and configured to be inserted through a conduit and/or channel, a flow path in which a suction is acted by the suction section of the endoscope, which is formed to bring the lumen of the longitudinal member in communication with the conduit and/or channel, an accommodating section which is formed in the flow path, and accumulate the body fluid suctioned in the lumen by the suction section of the endoscope, and a sealing member configured to seal a space between the longitudinal member and the channel closer to a distal end of the longitudinal member than the suction port so that a fluid does not flow from the distal end side to a proximal end side of the longitudinal member.
  • a body fluid collection device configured to be used in combination with an endoscope having a channel and a suction section configured to suction the inside of the channel from a suction port in communication with the conduit and/or channel
  • the body fluid collection device comprises a longitudinal member having a lumen formed along a longitudinal axis and configured to be inserted through the channel, a flow path in which a suction is acted by the suction section of the endoscope, which is formed to bring the lumen of the longitudinal member in communication with the channel, an accommodating section which is formed in the flow path, and accumulate the body fluid suctioned in the lumen by the suction section of the endoscope, and a sealing member configured to seal a space between the longitudinal member and the channel closer to a distal end of the longitudinal member than the suction port so that a fluid does not flow from the distal end side to a proximal end side of the longitudinal member.
  • the endoscope of the present invention may be involved in evaluating disease, normal tissues, pharynx/larynx/esophagus/stomach/small intestine as well as disease diagnosis and management of airways (such as but not limited to trachea and bronchi) including endoscopic procedures (such as but not limited to biopsy, balloon dilation and lavage).
  • a method and system for diagnosing and treating infection or disease in which an individual takes a photograph of an infected or diseased area of a body using a camera connected to a microprocessor disclosed in US Patent No. 9,649,013 is contemplated.
  • a photograph may be sent to a diagnosing center having a server with a second microprocessor and a database of photographs correlated with different diseases and infections.
  • the second microprocessor scans the image received from the camera and compares it to the photographs in the database. If a match is found, the second microprocessor then notes the disease or bacteria corresponding to the matching photograph.
  • the second microprocessor searches an additional database correlated to the match, to further refine the diagnosis.
  • the second microprocessor searches the second database for a treatment corresponding to the identified disease or bacteria. Once a treatment is identified, information regarding this treatment is automatically sent to the individual's microprocessor.
  • the endoscope of the present invention may have a shaft connected to a camera, which can record video and still images seen through shaft.
  • the video and still images may be transmitted to a microprocessor via a cable.
  • the video and still images can also be displayed on a display screen.
  • a microprocessor may be connected to a communication device, which can be a modem.
  • the images obtained by a camera may be compared to an initial database stored inside a database connected to microprocessor, and if a match is found, then sent to a second database, accessible over the internet, for a more refined diagnosis.
  • the diagnosis and possible treatments are sent back to the physician, and can be displayed on a display, or can be communicated in another manner, such as by voice instructions or holographically onto an eyepiece or lenses worn by the physician during the procedure, so that the physician does not have to look away from the procedure to receive the diagnosis.
  • the holographic message could also be projected onto a lens of a microscope, or the endoscope, or even onto a wall or other surface.
  • the endoscope may have an extension attached to its distal end.
  • an extension can be inserted into the tissue of a patient so that a layer of cells lies on top of the top surface of the extension.
  • This layer can then be illuminated, either from behind, if the extension is translucent, or from the front, by the light source of the endoscope.
  • the layer can be the thickness of a single layer of cells.
  • the camera takes an image that is essentially a prepared slide for sending to a microprocessor.
  • the cells of the tissue being examined are more visible and the diagnosis can be made more easily. This procedure also saves the time and expense required in preparation of slides in a laboratory.
  • a non-invasive and minimally invasive denervation methods and systems for performing the same as disclosed in United States Patent 9,649,154 is also contemplated for the present invention.
  • a system and method can be used to denervate at least a portion of a bronchial tree.
  • An energy emitter of an instrument is percutaneously delivered to a treatment site and outputs energy to damage nerve tissue of the bronchial tree.
  • the denervation procedure can be performed without damaging non-targeted tissue.
  • Minimally invasive methods can be used to open airways to improve lung function in subjects with COPD, asthma, or the like. Different sections of the bronchial tree can be denervated while leaving airways intact to reduce recovery times.
  • a minimally invasive system capable of treating the respiratory system to enhance lung function may be utilized to treat a subject suffering from COPD, asthma, or the like and, thus, the lungs may perform poorly.
  • the system can be used to perform a denervation procedure.
  • the instrument can be used to attenuate the transmission of signals traveling along the vagus nerves that cause or mediate muscle contractions, mucus production, inflammation, edema, and the like. Attenuation can include, without limitation, hindering, limiting, blocking, and/or interrupting the transmission of signals. For example, the attenuation can include decreasing signal amplitude of nerve signals or weakening the transmission of nerve signals. Decreasing or stopping nervous system input to distal airways can alter airway smooth muscle tone, airway mucus production, airway inflammation, and the like, thereby controlling airflow into and out of the lungs.
  • Decreasing or stopping sensory input from the airways and lungs to local effector cells or to the central nervous system can also decrease reflex bronchoconstriction, reflex mucous production, release of inflammatory mediators, and nervous system input to other cells in the lungs or organs in the body that may cause airway wall edema.
  • the nervous system input can be decreased to correspondingly decrease airway smooth muscle tone.
  • the airway mucus production can be decreased a sufficient amount to cause a substantial decrease in coughing and/or in airflow resistance.
  • the airway inflammation can be decreased a sufficient amount to cause a substantial decrease in airflow resistance and ongoing inflammatory injury to the airway wall.
  • Signal attenuation may allow the smooth muscles to relax, prevent, limit, or substantially eliminate mucus production by mucous producing cells, and decrease inflammation. In this manner, healthy and/or diseased airways can be altered to adjust lung function.
  • various types of questionnaires or tests can be used to assess the subject's response to the treatment. If needed or desired, additional procedures can be performed to reduce the frequency of coughing, decrease breathlessness, decrease wheezing, and the like.
  • Main bronchi i.e., airway generation
  • the left and right main bronchi are treated at locations along the left and right lung roots and outside of the left and right lungs.
  • Treatment sites can be distal to where vagus nerve branches connect to the trachea and the main bronchi and proximal to the lungs.
  • a single treatment session involving two therapy applications can be used to treat most of or the entire bronchial tree.
  • Substantially all of the bronchial branches extending into the lungs may be affected to provide a high level of therapeutic effectiveness. Because the bronchial arteries in the main bronchi have relatively large diameters and high heat sinking capacities, the bronchial arteries may be protected from unintended damage due to the treatment.
  • Nerve tissue distal to the main bronchi can also be treated, such as nerve tissue positioned outside the lung which run along the right or left main bronchi, the lobar bronchii, and bronchus intermedius.
  • the intermediate bronchus is formed by a portion of the right main bronchus and includes origin of the middle and lower lobar bronchii.
  • the distal section can be positioned alongside higher generation airways (e.g., airway generations >2) to affect remote distal portions of the bronchial tree. Different procedures can be performed to denervate a portion of a lobe, an entire lobe, multiple lobes, or one lung or both lungs.
  • the lobar bronchi are treated to denervate lung lobes.
  • one or more treatment sites along a lobar bronchus may be targeted to denervate an entire lobe connected to that lobar bronchus.
  • Left lobar bronchi can be treated to affect the left superior lobe and/or the left inferior lobe.
  • Right lobar bronchi can be treated to affect the right superior lobe, the right middle lobe, and/or the right inferior lobe.
  • Lobes can be treated concurrently or sequentially.
  • a physician can treat one lobe. Based on the effectiveness of the treatment, the physician can concurrently or sequentially treat additional lobe(s). In this manner, different isolated regions of the bronchial tree can be treated.
  • Each segmental bronchus may be treated by delivering energy to a single treatment site along each segmental bronchus.
  • Nerve tissue of each segmental bronchus of the right lung can be destroyed. In some procedures, one to ten applications of energy can treat most of or substantially all of the right lung. Depending on the anatomical structure of the bronchial tree, segmental bronchi can often be denervated using one or two applications of energy.
  • Function of other tissue or anatomical features such as the mucous glands, cilia, smooth muscle, body vessels (e.g., blood vessels), and the like can be maintained when nerve tissue is ablated.
  • Nerve tissue includes nerve cells, nerve fibers, dendrites, and supporting tissue, such as neuroglia.
  • Nerve cells transmit electrical impulses, and nerve fibers are prolonged axons that conduct the impulses.
  • the electrical impulses are converted to chemical signals to communicate with effector cells or other nerve cells.
  • a portion of an airway of the bronchial tree can be denervated to attenuate one or more nervous system signals transmitted by nerve tissue. Denervating can include damaging all of the nerve tissue of a section of a nerve trunk along an airway to stop substantially all the signals from traveling through the damaged section of the nerve trunk to more distal locations along the bronchial tree or from the bronchial tree more proximally to the central nervous system.
  • signals that travel along nerve fibers that go directly from sensory receptors (e.g., cough and irritant receptors) in the airway to nearby effector cells e.g., postganglionic nerve cells, smooth muscle cells, mucous cells, inflammatory cells, and vascular cells
  • effector cells e.g., postganglionic nerve cells, smooth muscle cells, mucous cells, inflammatory cells, and vascular cells
  • the bronchial blood vessels along the treated airway can deliver a similar amount of blood to bronchial wall tissues and the pulmonary blood vessels along the treated airway can deliver a similar amount of blood to the alveolar sacs at the distal regions of the bronchial tree before and after treatment. These blood vessels can continue to transport blood to maintain sufficient gas exchange.
  • airway smooth muscle is not damaged to a significant extent.
  • a relatively small section of smooth muscle in an airway wall which does not appreciably impact respiratory function may be reversibly altered. If energy is used to destroy the nerve tissue outside of the airways, a therapeutically effective amount of energy does not reach a significant portion of the non-targeted smooth muscle tissue.
  • Any number of procedures can be performed on one or more of these nerve trunks to affect the portion of the lung associated with those nerve trunks. Because some of the nerve tissue in the network of nerve trunks coalesces into other nerves (e.g., nerves connected to the esophagus, nerves though the chest and into the abdomen, and the like), specific sites can be treated to minimize, limit, or substantially eliminate unwanted damage of other nerves.
  • Some fibers of anterior and posterior pulmonary plexuses coalesce into small nerve trunks which extend along the outer surfaces of the trachea and the branching bronchi and bronchioles as they travel outward into the lungs. Along the branching bronchi, these small nerve trunks continually ramify with each other and send fibers into the walls of the airways.
  • An activatable element in the form of an energy emitter is configured to damage nerve tissue, such as a vagus nerve branch.
  • Vagus nerve tissue includes efferent fibers and afferent fibers oriented parallel to one another within a nerve branch.
  • the efferent nerve tissue transmits signals from the brain to airway effector cells, mostly airway smooth muscle cells and mucus producing cells.
  • the afferent nerve tissue transmits signals from airway sensory receptors, which respond to irritants, and stretch to the brain. There is a constant, baseline tonic activity of the efferent vagus nerve tissues to the airways which causes a baseline level of smooth muscle contraction and mucous secretion.
  • the energy emitter can ablate the efferent and/or the afferent tissues to control airway smooth muscle (e.g., innervate smooth muscle), mucous secretion, nervous mediated inflammation, and tissue fluid content (e.g., edema).
  • airway smooth muscle e.g., innervate smooth muscle
  • mucous secretion e.g., mucous secretion
  • nervous mediated inflammation e.g., edema
  • tissue fluid content e.g., edema
  • the instrument can be delivered through a percutaneous opening in the chest, back, or other suitable location.
  • Potential access locations include between the ribs in the chest, between the ribs in a para-sternal location, between the ribs along the back or side of the subject, from a subxiphoid location in the chest, or through the pre-sternal notch superior to the manubrium.
  • percutaneous and derivations thereof refer generally to medical procedures that involve accessing internal organs via an opening, such as a puncture or small incision in a subject's skin and may involve the use of an access apparatus, such as the access apparatus.
  • the access apparatus can be in the form of a trocar, a cannula, a port, a sleeve, or other less-invasive access device, along with an endoscope.
  • the distal section can be relatively sharp to puncture and pass through tissue.
  • a stylet can be positioned in a lumen in the instrument and can have a relatively sharp tip to directly puncture the skin. After the stylet is inserted into the skin, the instrument can be moved along the stylet through the user's skin into and between internal organs.
  • the instrument may be visualized using fluoroscopy, computed tomography (CT), thoracoscopy, ultrasound, or other imaging modalities, and may have one or more markers (e.g., radiopaque marks), or dyes (e.g., radiopaque dyes), or other visual features.
  • markers e.g., radiopaque marks
  • dyes e.g., radiopaque dyes
  • the visual features can help increase the instrument's visibility, including the instrument's radiopacity or ultrasonic visibility.
  • An instrument shaft can be made of a generally flexible material to allow delivery along tortuous paths to remote and deep sites.
  • the distal section can be steered or otherwise manipulated using a steering assembly.
  • the distal section can be deflected laterally or shaped into a desired configuration to allow enhanced navigation around thoracic structures.
  • the distal section can assume a treatment configuration.
  • the treatment configuration can be a serpentine configuration, a helical configuration, a spiral configuration, a straight configuration, or the like.
  • Conventional electrode catheters or ablation catheters can also be used to perform at least some methods disclosed herein.
  • the term "energy” is broadly construed to include, without limitation, thermal energy, cryogenic energy (e.g., cooling energy), electrical energy, acoustic energy (e.g., ultrasonic energy), microwave energy, radiofrequency energy, high voltage energy, mechanical energy, ionizing radiation, optical energy (e.g., light energy), and combinations thereof, as well as other types of energy suitable for treating tissue.
  • the energy emitter 209 of FIG. 3 can include one or more electrodes (e.g., needle electrodes, bipolar electrodes, or monopolar electrodes) for outputting energy, such as ultrasound energy, radiofrequency (RF) energy, radiation, or the like.
  • the electrodes can output a sufficient amount of RF energy to form a lesion at the periphery of the airway.
  • a lesion can have a depth less than or equal to about 2 mm.
  • the lesion depth D can be less than about 1 mm to localize tissue damage.
  • Thermal energy emitters can be resistive heaters or thermally conducting elements.
  • the energy emitter can include one or more microwave antennas.
  • the energy emitter includes one or more lenses or reflector(s) capable of outputting light delivered via one or more optical fibers.
  • An external light source e.g., a lamp, an array of light emitting diodes, or the like
  • the energy emitter is a light source, such as a light-emitting diode (LED) or laser diode.
  • Photodynamic agents or light activatable agents can be used to ablate tissue.
  • the energy emitter can include a dispenser (e.g., a nozzle, an orifice, etc.) for delivering a substance (e.g., a chemical agent, a high temperature fluid, a cutting jet, etc.) that kills or damages targeted tissue.
  • a dispenser e.g., a nozzle, an orifice, etc.
  • a substance e.g., a chemical agent, a high temperature fluid, a cutting jet, etc.
  • Multiple emitters can be used sequentially or simultaneously to treat tissue.
  • an energy emitter in the form of a dispenser can mechanically damage surface tissue while another energy emitter outputs radiofrequency or microwave energy to destroy deep tissue.
  • Light sources or elements used in conjunction with the scope may include micro light emitting diodes (pLEDs or microLEDs) light sources.
  • a light source may include one or more microscopic LEDs.
  • a pLED light source may include a multitude of microscopic LEDs.
  • MicroLEDs may emit light across a broad range of wavelengths. In some instances, light from a specific wavelength may be emitted based on the end-use.
  • a pLED light source for example, an array of pLEDs and/or individual pLEDs may be constructed such that specific wavelengths are emitted. For example, white light, blue light, ultraviolet light, and/or a variable light spectrum may be emitted depending on the use.
  • the pLED light source used in a scope may be capable of delivering energy having a wavelength within a range from about 200 nm to about 800 nm. For example, some pLED light source may emit wavelengths in a range from about 400 nm to about 700 nm. In a particular example, when a blue light is desired one or more microLEDs may emit light having a wavelength in a range from about 450 nm to about 495 nm.
  • a configuration of microLEDs on a scope may be constructed such that at different locations on the scope it may be desirable to emit differing wavelengths of energy, for example, light.
  • the microLEDs may extend through the elongated member of the shaft, for example, in the internal conduit. It may be desirable in some embodiments for the microLEDs to be at least partially exposed at various positions along the elongated member. In some embodiments, the microLEDs deliver light at the distal element.
  • MicroLEDs may be positioned at various locations on a scope.
  • an array of microLEDs may be used as a light source positioned on and/or embedded in endoscopy shaft.
  • channels for lighting elements such as a lightpipe, fiber optic elements, or clear epoxy may be used to house one or more pLEDs such that the pLEDs are embedded in the shaft.
  • the microLED 4700 is embedded in the shaft 4704 in channel 4702.
  • the pLED may extend to the tip of the shaft.
  • embedded microLEDs 4706 are present in at least a portion of shaft 4704.
  • the microLEDs may be positioned surrounding at least a portion of the shaft as a wrap.
  • FIG. 44 depicts a microLED wrap area 4708.
  • MicroLEDs may be positioned such that they form a continuous surface of microLEDs on the portion of the scope covered in the wrap.
  • clusters of microLEDs 4712 are positioned in the wrap spaced apart from each other as is shown in Fig. 45.
  • an embodiment may include individual pLEDs spaced apart from each other.
  • FIG. 45 shows a depiction of a front view of a distal element for an endoscope.
  • MicroLED elements 4712 are shown as part of a wrap on a surface of the scope 4714 proximate to camera sensor 4716.
  • Fig. 46 shows microLED elements 4718 on the face of the scope 4720 proximate to camera sensor 4716.
  • FIG. 47 is a drawing depicting a top view of an illustrative example of a distal element for an endoscope.
  • MicroLED elements 4722, 4728 are present on distal element 4724 of shaft 4726. MicroLED elements may be placed in various positions along the shaft.
  • FIG. 48 is a drawing depicting a perspective view of an illustrative example of a handle element 4730 for a scope, for example an endoscope.
  • Elongated element 4732 may include microLED elements extending from the handle element to the distal element.
  • the microLEDs may differ from each other in capabilities.
  • there may be a desire to control the light emission such that one or more properties have a value within a predetermined range based on the use of the scope.
  • Properties related to the emission of light from a pLED may be controlled such that light emitted is within a specific wavelength, a range of wavelengths, a specific luminosity factor, a specific illuminance, a specific intensity, a specific beam and/or field angle, and/or at a specific location on the scope.
  • Specific values and/or desired ranges may be pre-determined based on the use of the light source and/or one or more properties of the individual pLEDs.
  • microLEDs light sources may require less energy than other conventional light sources currently used in scopes. Further, in some instances microLED may have a higher total brightness than conventional lights sources. In addition, microLEDs may be a higher efficiency in terms of lux/W. MicroLEDs may have a longer lifespan than conventionally available light sources for scopes.
  • the distal section can mechanically damage tissue by cutting, abrading, or tearing nerve tissue. A minimal amount of tissue adjacent to the nerve tissue 45 may also be damaged. The damaged non-targeted tissue can heal without any appreciable decrease in lung function.
  • the distal section comprises a morcellation device.
  • the distal section can comprise one or more energy absorption devices for absorbing energy from a remote energy source.
  • the remote energy source can be a microwave energy source, a radiofrequency energy source, an ultrasound energy source, or a radiation energy source and can be positioned outside the subject's body or located in another body structure, such as the esophagus, airway (trachea or bronchus), or elsewhere in the subject's body.
  • the distal section can be heated by the remote energy source to a sufficient temperature to damage targeted tissue.
  • the element can include a reflector to reflect energy from a remote energy source. The reflected energy can create a pattern (e.g., interference pattern) to control the amplitude of energy waves at the target site.
  • the controller can include one or more processors, microprocessors, digital signal processors (DSPs), field programmable gate arrays (FPGA), and/or application-specific integrated circuits (ASICs), memory devices, buses, power sources, and the like.
  • DSPs digital signal processors
  • FPGA field programmable gate arrays
  • ASICs application-specific integrated circuits
  • the controller can include a processor in communication with one or more memory devices. Buses can link an internal or external power supply to the processor.
  • the memories may take a variety of forms, including, for example, one or more buffers, registers, random access memories (RAMs), and/or read only memories (ROMs).
  • the controller may also include a display, such as a screen, and can be a closed loop system, whereby the power to the distal section s controlled based upon feedback signals from one or more sensors configured to transmit (or send) one or more signals indicative of one or more tissue characteristics, energy distribution, tissue temperature, or any other measurable parameters of interest. Based on those readings, the controller can then adjust operation of the distal section.
  • the controller can control the amount of energy delivered from the energy source (e.g., one or more batteries or other energy storage devices) to the energy emitter.
  • the sensor can be a temperature sensor. If the temperature of the peripheral tissue of the airway becomes too hot, the distal section can cool the tissue using one or more Peltier devices, cooling balloons, or other types of cooling features.
  • the controller can be an open loop system wherein the operation is set by user input.
  • the system may be set to a fixed power mode. It is contemplated that the system can be repeatedly switched between a closed loop mode and an open loop mode to treat different types of sites.
  • the instrument can also include any number of different types of visualization devices, such as cameras, optical fibers, lenses, or mirrors.
  • Ultrasound or other types of energy-based viewing systems can be used to visualize deep targeted tissues. Surface tissues can be targeted using direct visualization while deeper tissues are subsequently targeted using ultrasound.
  • the term "ablate,” including variations thereof, refers, without limitation, to destroying or permanently damaging, injuring, or traumatizing tissue.
  • ablation may include localized tissue destruction, cell lysis, cell size reduction, necrosis, or combinations thereof.
  • ablation includes sufficiently altering nerve tissue properties to substantially block transmission of electrical signals through the ablated nerve tissue. Ablating all of the nerve trunks along the airway prevents nerve signals from traveling distally along the airway and causes the smooth muscle to relax to open the airway.
  • RF energy causes heating of the nerve tissue and, ultimately, the formation of the lesion.
  • the nerve tissue is destroyed without removing a significant amount of airway tissue, if any, to preserve the integrity of the airway.
  • the lesion can be left in the body to avoid potential complications from removing airway tissue.
  • the healthy airway wall prevents gas escape across the airway wall.
  • the smooth muscle and interior lining of the airway can remain substantially undamaged to allow mucociliary transport and other bodily functions that are important to overall health. This reduces the recovery time and avoids or mitigates problems associated with surgical techniques of removing or cutting through the airway wall.
  • an intact denervated airway can also ensure that distal regions of the lung continue to function.
  • Large lesions can extend through the airway wall and can be formed to destroy unwanted tissue (e.g., cancerous tissues) positioned along the inner surface. Differential cooling can be used to form lesions buried deep within the sidewall, spaced apart from the interior and exterior surfaces of the airway, or any other suitable location. The instrument can cool tissues to keep the nontargeted tissue below a temperature at which cell death occurs.
  • the distal section has a cooling member (e.g., a cooling balloon) that absorbs thermal energy to keep nontargeted regions of the airway wall at or below a desired temperature.
  • a cooling member e.g., a cooling balloon
  • the shape and size of lesions can also be adjusted as desired.
  • Natural body functions can help prevent, reduce, or limit tissue damage. If the bronchial artery branch is heated, blood within the blood vessels can absorb the thermal energy and can then carry the thermal energy away from the heated section of the branches. The lesion can surround a region of the blood vessel 130 without destroying the vessel. After the treatment is performed, the bronchial artery branches can continue to maintain the health of lung tissue.
  • the lesion depth can be kept at or below a desired depth by controlling the amount of delivered energy. To avoid reaching smooth muscle, the depth can be equal to or less than about 3 mm, 2 mm, or 1 mm. For thick airway walls, the lesion depth can be equal to or less than about 3 mm. For medium size airway walls, the lesion depth can be equal to or less than about 2 mm. In young children with thin airway walls, the lesion depth can be equal to or less than about 1 mm.
  • the lateral dimensions (e.g., width, length, etc.) of the lesion can be adjusted to ensure that targeted tissue is ablated.
  • the instrument can be delivered along the trachea, esophagus, pharynx, or other body structure in the vicinity of the treatment site.
  • the instrument can extend through one or more organs to position an energy emitter 314 proximate to the targeted tissue.
  • the instrument can cool interior regions of the airway wall to cause the formation of the lesion at the outer periphery of the airway wall.
  • the RF energy can travel between bipolar electrodes. Tissue impedance causes heating that can reach sufficiently high temperatures to cause cell death.
  • the instrument can cool the airway to keep the nontargeted tissue below a temperature at which cell death occurs.
  • Thermal energy can be absorbed by the instrument to keep the exterior regions of the airway wall at or below a desired temperature. Both instruments can provide cooling to form lesions generally midway through the airway wall. The amount of energy delivered and cooling capacity provided by the instruments can be adjusted to shape and form lesions at different locations.
  • At least one of the instruments can be adapted to tunnel through tissue or between adjacent structures to allow it to reach the desired location, for example, along the bronchi. Additionally or alternatively, the instruments may be adapted to adhere to or slide smoothly along tissue or to be urged against a structure (e.g., trachea, esophagus, and/or bronchi) as the instrument is advanced.
  • a structure e.g., trachea, esophagus, and/or bronchi
  • a wide range of different types of guides can partially or completely surround a structure, such as the esophagus, trachea, or bronchus.
  • Guides may include, without limitation, a plurality of arms (e.g., a pair of arms, a set of curved or straight arms, or the like), a ring (e.g., a split ring or a continuous ring), or the like.
  • Cartilage rings or cartilage layers typically have a significantly larger electrical resistance than airway soft tissue (e.g., smooth muscle or connective tissue).
  • Airway cartilage can impede the energy flow (e.g., electrical radiofrequency current flow) and makes the formation of therapeutic lesions to affect airway trunks challenging when the electrode is next to cartilage.
  • the electrodes can be positioned to avoid energy flow through cartilage.
  • the electrode can be positioned between cartilage rings.
  • Most or substantially all of the outputted energy can be delivered between the rings in some procedures.
  • Tissue impedance can be measured to determine whether a particular electrode is positioned next to a cartilage ring, in an intercartilaginous space, or at another location.
  • the instrument may have a lumen to receive a stylet to straighten and stiffen the preshaped distal section during introduction. After insertion, the stylet can be withdrawn to allow the preshaped distal section to assume a treatment configuration (e.g., a spiral configuration, a helical configuration, or the like). Alternatively, the distal section may be relatively flexible and straight during introduction. A stylet having a shape corresponding to a desired shape may be inserted into the instrument to impart the desired shape to the distal section. In a further embodiment, the instrument may be shapeable or steerable using an actuator at its proximal end to allow it to be steered so as to surround the target tubular structure.
  • a treatment configuration e.g., a spiral configuration, a helical configuration, or the like.
  • the distal section may be relatively flexible and straight during introduction.
  • a stylet having a shape corresponding to a desired shape may be inserted into the instrument to impart the desired shape to the distal section.
  • the instrument may be shapeable or steer
  • a system for non-invasively denervating a bronchial tree may include an external energy source connected to an energy delivery system.
  • the external energy source can emit a beam of radiation to targeted tissue, such as nerve tissue.
  • the beam of radiation can destroy the targeted tissue.
  • the system can include, or be in the form of, a CyberKnife.RTM. Robotic Radiosurgery System from Accuray.RTM., a TomoTherapy.RTM. radiation therapy system, or similar type of systems capable of targeting moving tissue, thereby mitigating or limiting damage to non-targeted tissue.
  • Beam radiation may be delivered from different remote locations to damage deep nerve tissue without damaging intervening tissues.
  • the source of beam radiation may be a beam emitter of an external beam radiotherapy system or a stereotactic radiation system. Because the lungs and bronchi move as the subject breathes, the system can be adapted to target moving tissues. By positioning the radiation beam emitter at various locations relative to the patient's body, such systems may be used to deliver a radiation beam from various angles to the targeted nerve tissue.
  • the dose of radiation given to intervening tissues may be insufficient to cause injury, but the total dose given to the target nerve tissue is high enough to damage (e.g., ablate) the targeted tissue.
  • Ultrasound can be used to damage targeted tissue.
  • High intensity focused ultrasound may be used to target and damage the nerve tissue.
  • the external energy source can be a HIFU emission device.
  • a catheter, an intra-luminal instrument, or other type of instrument for insertion into the body can include a HIFU emission device.
  • Such embodiments are well suited for delivery through another body structure, such as the esophagus or airway, to treat target tissue of an airway.
  • the HIFU instrument may include ultrasound imaging capability to locate the targeted tissues.
  • the HIFU instrument can emit a plurality of ultrasound "beams" from different angles toward the target tissues. The intensity of any one of the beams can be insufficient to damage intervening tissues. The beams can interfere at the target site and together have sufficient magnitude to damage the target nerve tissue.
  • the HIFU-based systems can be adapted to target moving tissues.
  • such systems may have a computer-controlled positioning system which receives input from an ultrasound or other imaging system and commands a positioning system in real time to maintain the HIFU device in a fixed position relative to the target structure.
  • Instruments disclosed herein may be entirely or partially controlled robotically or by a computer. Instruments may be attachable to a computer-controlled robotic manipulator which moves and steers the instruments.
  • Robotic systems such as the da Vinci.RTM. Surgical System from Intuitive Surgical or the Sensei Robotic Catheter system from Hansen Medical, Inc., or similar types of robotic systems, can be used.
  • the instruments can have a proximal connector (e.g., an adaptor mechanism) that connects with a complementary fitting on the robotic system and links movable mechanisms of the instrument with control mechanisms in the robotic system.
  • the instrument connector can also provide electrical couplings for wires leading to energy emitters, electrodes, microwave antennae, or other electrically powered devices.
  • the instrument may further include sensor devices (e.g., temperature sensors, tissue impedance sensors, etc.) which are also coupled via the connector of the robotic system.
  • the robotic system can include a control module that allows the physician to move and activate the denervation instrument while visualizing the location of the instrument within the chest, for example, using thoracoscopy, fluoroscopy, ultrasound, or other suitable visualization technology.
  • the instrument may also be computer controlled, with or without robotic manipulation.
  • a computer may receive feedback (e.g., sensory data) from sensors carried by the instrument or elsewhere to control positioning, power delivery, or other parameters of interest.
  • a computer may be used to receive temperature data from temperature sensors of the instrument and to control power delivery to avoid overheating of tissue.
  • the instruments can access sites through blood vessels, as well as external to the organs.
  • Robot surgery including robotic catheter systems
  • natural orifice access methods and minimally invasive access methods such as using trocar access methods and thoracoscopy have provided clinicians with access procedure locations within the human body and also minimized patient morbidity and complications due to surgery.
  • the assemblies, methods, and systems described herein can be used to affect tissue which is located on the outside of hollow organs, such as the lung, esophagus, nasal cavity, sinus, colon, vascular vessels and the like or other solid organs.
  • Various types of activatable elements e.g., energy emitters
  • the activatable elements can be sufficiently small to facilitate percutaneous delivery to minimize or limit trauma to the patient.
  • the embodiments disclosed herein can treat the digestive system, nervous system, vascular system, or other systems.
  • the treatment systems and its components disclosed herein can be used as an adjunct during another medical procedure, such as minimally invasive procedures, open procedures, semi-open procedures, or other surgical procedures (e.g., lung volume reduction surgery) that provide access to a desired target site.
  • Various surgical procedures on the chest may provide access to lung tissue, the bronchial tree, or the like.
  • Access techniques and procedures used to provide access to a target region can be performed by a surgeon and/or a robotic system. Those skilled in the art recognize that there are many different ways that a target region can be accessed.
  • the present invention also contemplates accessory devices which may be involved, for example but not limited to, cessation of bleeding/cautery or removal of a foreign body.
  • An accessory device is disclosed in US Patent No. 8,007,432 and can include an insertion member and a control wire.
  • the insertion member can have a lumen for receiving a tool therethrough, such as an endoscope.
  • the control wire can be coupled to the insertion member and have a distal portion extending distally from the insertion member and be adapted to receive and to manipulate a tool extending through the insertion member.
  • the control wire can have a wide variety of configurations, and in certain exemplary embodiments the control wire can be slidably received in one or more control wire lumens formed through the insertion member. In use, the control wire can be manipulated, for example by axially sliding the control wire in one or more control wire lumens to control a tool.
  • the accessory device can have a variety of configurations, but in the illustrated embodiment the accessory device includes an insertion member in the form of an elongate sheath and an accessory channel.
  • the elongate sheath can have a distal end with a control wire coupled thereto and a proximal end with a handle and a control mechanism coupled thereto.
  • the elongate sheath can have an endoscope disposed therethrough.
  • the distal face of the endoscope can have a viewing instrument, for example a lens, one or more lighting elements, for example lights or fiber optics, and a lumen formed therein for receiving one or more tools, such as viewing instruments, graspers, cutting devices, irrigation devices, and so on.
  • the elongate sheath can also have a mating element such as a track for mating with a complementary mating element formed on the accessory channel, such as a rail.
  • the elongate sheath can have one or more control wire lumens formed therein and extending between the proximal and distal ends thereof.
  • the control wire can be slidably disposed in the control wire lumens.
  • the control mechanism can be coupled to the control wire and can be adapted to move the control wire, for example, by manipulation of a knob. Movement of the control wire can include, for example, axially sliding the control wire within one or both of the control wire lumens or axially rotating the control wire. In use, movement of the control wire can be effective to manipulate a tool.
  • the tool for example, can extend distally from the lumen in the endoscope, or from the accessory channel, or the tool can be separate from or spaced apart from the elongate sheath.
  • the manipulation can take many forms, but as one example, a portion of the tool can be pulled into a viewing window of the endoscope.
  • the accessory device need not include an accessory channel.
  • the insertion member can be in the form of an elongate sheath with a control wire coupled thereto.
  • the elongate sheath need not include a mating element such as a track adapted for mating to the accessory channel.
  • movement of the control wire can be effective to manipulate a tool extending distally from a lumen formed in an endoscope, such as the lumen in the endoscope.
  • an alternate embodiment of an accessory device can have an insertion member in the form of an endoscope.
  • a lumen is formed in the endoscope for receiving a tool therethrough and the distal end of the endoscope has a viewing element and a first and second lighting elements.
  • the endoscope may have a first and second control wire lumens formed therein. In use, the control wire can be moved to manipulate a tool extending distally from the lumen and/or a tool adjacent to the accessory device, such as another tool disposed at the surgical site.
  • the accessory device can have a variety of other configurations, as one skilled in the art will understand.
  • the accessory device can have multiple accessory channels, lumens for receiving tools, and/or elongate sheaths.
  • the accessory device need not receive a tool, and instead the control wire can be adapted to manipulate a tool inserted separately to the surgical site within the body.
  • Any of the previously described lumens such as an accessory channel lumen and/or endoscope lumen, can receive surgical materials, irrigating fluids, antiseptic agents, or organic substances, etc., therethrough in addition to or instead of tools.
  • the accessory device can have multiple control wires which can be movable within control wire lumens and/or fixedly attached to the accessory device.
  • the control wires can be arranged to provide multiple loops or arcs at the distal end of the accessory device, and/or can be arranged in a fashion similar to that of a single control wire.
  • control wire lumens can be associated with the accessory channel instead of or in additional to elongate sheath.
  • an accessory device such as the accessory device can be positioned at a surgical site.
  • the accessory device can be positioned in the body by inserting the distal end of the accessory device into a natural orifice such as the mouth, or through an incision made in the body.
  • the accessory device can be advanced distally through a body lumen to a desired position.
  • the insertion may be associated with or preceded by any number of procedures to lubricate, flex, shape, measure, steer, turn, rotate, and/or guide the accessory device into the body.
  • the insertion may also be assisted by or performed with a viewing instrument such as an endoscope for showing the path of the accessory device within the body.
  • inserting the accessory device can include inserting an endoscope through an elongate sheath, and mating an accessory channel to an elongate sheath.
  • the rail of the accessory channel can be slidably mated to the track of the elongate sheath, and the accessory channel can be advanced to a desired position along the elongate sheath.
  • Such mating can be performed at any time, including before and after part of the accessory device is inserted in the body.
  • the accessory channel can be unmated, e.g., by sliding the accessory channel proximally along the elongate shaft, and re-mated any number of times to re- introduce the accessory channel or to introduce other accessory channels.
  • Surgical tools as well as materials can be inserted through one or more lumens in the accessory device.
  • a tool can be inserted through the elongate sheath, through a lumen formed in an endoscope disposed in the elongate sheath, and/or through the accessory channel. Multiple tools can be inserted through a single lumen or through separate lumens.
  • a tool can also be inserted into the body separately from the accessory device, for example, not through any lumen formed therein.
  • a tool can be advanced beyond the distal end of the elongate sheath and can be positioned, articulated, and maneuvered at the surgical site, as may be called for by a surgical procedure.
  • the devices disclosed herein can also be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure.
  • reconditioning of a device can utilize a variety of techniques for disassembly, cleaning and/or replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
  • the invention described herein will be processed before surgery.
  • a new or used tool is obtained and if necessary cleaned.
  • the tool can then be sterilized.
  • the tool is placed in a closed and sealed container, such as a plastic or TYVEK bag.
  • the container and tool are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons.
  • the radiation kills bacteria on the instrument and in the container.
  • the sterilized instrument can then be stored in the sterile container.
  • the sealed container keeps the instrument sterile until it is opened in the medical facility. It is preferred that the device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, or steam.
  • the invention also contemplates the use of the herein disclosed endoscope to study the gastrointestinal (GI) tract, in particular visualization of the GI tract contents and abnormalities as well as measurement of the GI tract.
  • GI gastrointestinal
  • a medical system disclosed in US Patent No. 9,675,526 for facilitating installation of a PEG device in a patient's body by utilizing an endoscope is contemplated.
  • Such a system comprises a needle configured to be disposed within an endoscope lumen of the endoscope and moveable along a longitudinal axis relative to the endoscope, wherein the needle includes a needle lumen extending therethrough; a safety cap for being placed on the outside of the patient's body, the safety cap having a cap lumen extending longitudinally therethrough, the cap lumen sized and configured to receive and secure the needle such that the needle lumen and cap lumen are in fluid communication, the cap lumen sized and structured to frictionally engage the needle to secure the needle to the safety cap; and a wire sized and configured to extend completely through the cap lumen and through at least a portion of the needle lumen.
  • the endoscope is generally flexible while retaining sufficient rigidity to allow it to be pushed through a patient's body toward the target site.
  • the type of endoscope may be configured to extend through a patient's mouth, the upper GI tract, and out through a hole in the patient's abdomen.
  • the length of the endoscope may be approximately 160 cm; however, other lengths could also be used that are long enough to extend out of the mouth, through the upper GI tract, and through the patient's abdomen.
  • various lengths could apply to patient's having various body sizes.
  • Known percutaneous endoscopic gastrostomy devices capable of being pulled through the GI tract by a wire having a looped end can also be used.
  • other tube-like devices for extending through tissue can also be used, including PEG devices and other devices that can be pushed through the upper GI tract over a guidewire.
  • the present invention also contemplates injection of medication via the endoscope of the present invention, preferably with a medical fluid device.
  • a medical fluid device Typical of medical fluid devices is a vascular access device that allows for the introduction of medication, antibiotics, chemotherapeutic agents, or a myriad of other fluids, to a previously established IV fluid flow system.
  • the access device may be used for withdrawing fluid from the subject for testing or other purposes.
  • the presence of one or more access devices in the IV tubing sets eliminates the need for phlebotomizing the subject repeatedly and allows for immediate administration of medication or other fluids directly into the subject.
  • access devices are well known in the medical field. Although varying in the details of their construction, these devices usually include an access site for introduction or withdrawal of medical fluids through the access device.
  • these devices can include a housing that defines an access opening for the introduction or withdrawal of medical fluids through the housing, and a resilient valve member or gland that normally closes the access site.
  • the valve member may be a solid rubber or latex septum or be made of other elastomeric material that is pierceable by a needle, so that fluid can be injected into or withdrawn from the access device.
  • valve member may comprise a septum or the like with a preformed but normally closed aperture or slit that is adapted to receive a specially designed blunt cannula therethrough.
  • Other types of access devices are designed for use with connecting apparatus employing standard male luers. Such an access device is commonly referred to as a “luer access device” or “luer-activated device,” or “LAD.” LADS of various forms or designs are illustrated in U.S. Patent Nos. 6,682,509, 6,669,681, 6,039,302, 5,782,816, 5,730,418, 5,360,413, and 5,242,432.
  • the present invention also contemplates use of the endoscope for a biopsy.
  • an additional biopsy needle attached to the endoscope of the present invention is contemplated.
  • a biopsy needle having a longitudinal channel formed within an inner conductor of a coaxial antenna is disclosed in US Patent No. 9,351,713.
  • the coaxial antenna terminates in a rigid insertion tip e.g. a ceramic cone that is insertable into biological tissue.
  • Microwave energy (e.g. having a frequency of 1 to 100 GHz) delivered to the coaxial antenna is emitted at the insertion tip.
  • the insertion tip may be arranged to match the impedance of the coaxial antenna to a predetermined tissue impedance.
  • the emitted radiation can be used to measure properties of or treat (e.g., ablate) tissue at the insertion tip.
  • Needle biopsy apparatus is also disclosed, in which a microwave energy is controllably delivered to a needle from a microwave generator.
  • the apparatus may include an impedance tuner to dynamically match the impedance of the needle with tissue at the insertion tip.
  • a biopsy needle insertable into tissue for introducing or extracting a sample therefrom, the needle having an elongate body terminating with an insertion tip, a longitudinal channel formed within the body for transporting the sample, and a coaxial antenna comprising an inner conductor and an outer conductor coaxial with the inner conductor and separated from it by a dielectric material, wherein the coaxial antenna is arranged to couple microwave energy to/from tissue at the insertion tip, and the channel is formed within the inner conductor or in an outer portion of the outer conductor.
  • the inner conductor may be a conductive layer along an inside wall of the channel.
  • the inner conductor is a conductive layer (tube) that defines the channel.
  • the outer conductor comprises a conductive layer formed on the outer surface of the elongate body.
  • the outer conductor may comprise a conductive layer formed on the dielectric material and an annular or part annular channel formed on that conductive layer.
  • the coupled microwave energy may be selectable either to measure properties of tissue at the insertion tip or to ablate tissue at the tip.
  • needle biopsy apparatus comprising a biopsy needle as described above and a microwave power source arranged to deliver microwave frequency energy to the coaxial antenna in the needle in order to measure and/or ablate tissue at the insertion tip of the needle.
  • the apparatus may include a dynamic impedance tuner arranged to adjust the impedance of the needle e.g. to match the impedance of the tissue at the insertion tip in order to ensure even (uniform) energy delivery into the tissue.
  • This aspect of the invention offers an advantage in that it enables uniform ablation of the channel through which the antenna is inserted to prevent the occurrence of seeding.
  • the ability to dynamically match into various tissue structures prevents uneven ablation due to variations in matching to various tissue types as the tip of the antenna moves through the various structures.
  • the needle antenna described in this specification can couple microwave frequency energy into a co-axial structure for the purpose of making tissue type/state measurements, and/or for performing controlled tissue ablation, and has a hollow tube center conductor to enable tissue biopsies to be performed before, after, or during the tissue ablation process.
  • the structure disclosed in the current invention may, therefore, be considered as a tri functional needle antenna.
  • the frequency of choice used in the current invention, and the microwave aspects of the design of the tri -functional antenna structure makes it possible to measure information regarding the state of the biological tissue at the same location (position) as where the tissue biopsy is to be physically taken, i.e. at the distal tip.
  • microwave frequency means a frequency range of between 1 GHz to 100 GHz, preferably 5 GHz to 60 GHz. Higher frequencies, e.g. up to 200 GHz may also be used. More preferably, the frequency source used operates at a frequency of between 14 GHz and 15 GHz, and, even more preferably, operates at a spot frequency of 14.5 GHz.
  • a dynamically adjustable tuning filter for example, a waveguide cavity containing three tuning stubs with a spacing of a quarter of the guide wavelength at the frequency of interest, to create a conjugate match between the distal tip of the needle antenna and the load presented by the biological tissue structure.
  • the tuning filter is positioned between the output from the power amplifier and the distal tip of the needle antenna to enable the output impedance of the amplifier to be matched to the input impedance of the tuning filter, and the output impedance of the tuning filter to be matched to the impedance of the biological tissue. This feature enables the needle antenna to be used to perform controlled ablation of a volume of cancerous tissue or to perform controlled ablation (or sealing) of the needle track (or channel).
  • the ability of the needle antenna to convey information back to the measurement system to allow dynamic impedance matching to be performed between the changing tissue impedance and the generator enables the energy delivered into the various tissue structures that exist along the track between the site where the tissue biopsy (or the tumor ablation) takes place and the outside world to be automatically regulated to provide uniform tissue ablation of healthy tissue structures en route, i.e. it may be desirable to ablate a channel of 4 mm diameter of healthy tissue along the track (or channel) to prevent the seeding of cancerous cells.
  • the ability of the needle antenna structure to allow for the mode of operation described above to be performed may be an additional feature of the current invention.
  • the invention may not be limited to using a single frequency source for performing controlled ablation and making dielectric measurement.
  • a plurality of frequency sources may be used.
  • the embodiments of the invention described below use a single frequency source operating at 14.5 GHz, which has the advantage of producing a high energy density for controlled ablation of small tumors and effective track (or channel) sealing, and a small enough radiation distance to allow for dielectric measurements that are localized to the end of the distal tip to be performed.
  • the advantage of using lower microwave frequencies for tumor ablation is that the larger penetration depths associated with low frequency microwave energy may be beneficial in terms of producing effective ablation of large tumors, and the advantage of using higher microwave frequencies for dielectric measurement is that the small radiation distances associated with high frequency microwave energy may be beneficial in terms of effectively performing local tissue measurements that are unaffected by surrounding tissue structures.
  • a surgical location monitoring system and method disclosed in US Patent No. 9,566,123 may be adapted for the present invention.
  • a computer generally includes a processor for executing instructions and memory for storing instructions and data, including interfaces to obtain and process imaging data.
  • the computer operating on such encoded instructions may become a specific type of machine, namely a computer particularly configured to perform the operations embodied by the series of instructions.
  • Some of the instructions may be adapted to produce signals that control operation of other machines and thus may operate through those control signals to transform materials far removed from the computer itself.
  • An algorithm is generally, conceived to be a self-consistent sequence of steps leading to a desired result. These steps are those requiring physical manipulations of physical quantities, observing and measuring scanned data representative of matter around the surgical site. Usually, though not necessarily, these quantities take the form of electrical or magnetic pulses or signals capable of being stored, transferred, transformed, combined, compared, and otherwise manipulated. It proves convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, symbols, characters, display data, terms, numbers, or the like as a reference to the physical items or manifestations in which such signals are embodied or expressed to capture the underlying data of an image. It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely used here as convenient labels applied to these quantities.
  • Data structures greatly facilitate data management by data processing systems, and are not accessible except through sophisticated software systems.
  • Data structures are not the information content of a memory, rather they represent specific electronic structural elements that impart or manifest a physical organization on the information stored in memory. More than mere abstraction, the data structures are specific electrical or magnetic structural elements in memory, which simultaneously represent complex data accurately, often data modeling physical characteristics of related items, and provide increased efficiency in computer operation.
  • the manipulations performed are often referred to in terms, such as comparing or adding, commonly associated with mental operations performed by a human operator. No such capability of a human operator is necessary, or desirable in most cases, in any of the operations described herein that form part of the present invention; the operations are machine operations.
  • Useful machines for performing the operations of the present invention include general-purpose digital computers or other similar devices. In all cases the distinction between the method operations in operating a computer and the method of computation itself should be recognized.
  • the present invention relates to a method and apparatus for operating a computer in processing electrical or other (e.g., mechanical, chemical) physical signals to generate other desired physical manifestations or signals.
  • the computer operates on software modules, which are collections of signals stored on a media that represents a series of machine instructions that enable the computer processor to perform the machine instructions that implement the algorithmic steps.
  • Such machine instructions may be the actual computer code the processor interprets to implement the instructions, or alternatively may be a higher level coding of the instructions that is interpreted to obtain the actual computer code.
  • the software module may also include a hardware component, wherein some aspects of the algorithm are performed by the circuitry itself rather as a result of an instruction.
  • the present invention also relates to an apparatus for performing these operations.
  • This apparatus may be specifically constructed for the required purposes or it may comprise a general- purpose computer as selectively activated or reconfigured by a computer program stored in the computer.
  • the algorithms presented herein are not inherently related to any particular computer or other apparatus unless explicitly indicated as requiring particular hardware.
  • the computer programs may communicate or relate to other programs or equipment through signals configured to particular protocols, which may or may not require specific hardware or programming to interact.
  • various general-purpose machines may be used with programs written in accordance with the teachings herein, or it may prove more convenient to construct more specialized apparatus to perform the required method steps. The required structure for a variety of these machines will appear from the description below.
  • the present invention may deal with "object-oriented” software, and particularly with an "object-oriented” operating system.
  • the "object-oriented” software is organized into “objects”, each comprising a block of computer instructions describing various procedures ("methods") to be performed in response to "messages" sent to the object or "events" which occur with the object.
  • Such operations include, for example, the manipulation of variables, the activation of an object by an external event, and the transmission of one or more messages to other objects.
  • a physical object has a corresponding software object that may collect and transmit observed data from the physical device to the software system. Such observed data may be accessed from the physical object and/or the software object merely as an item of convenience; therefore where "actual data” is used in the following description, such "actual data” may be from the instrument itself or from the corresponding software object or module.
  • Messages are sent and received between objects having certain functions and knowledge to carry out processes. Messages are generated in response to user instructions, for example, by a user activating an icon with a "mouse" pointer generating an event. Also, messages may be generated by an object in response to the receipt of a message. When one of the objects receives a message, the object carries out an operation (a message procedure) corresponding to the message and, if necessary, returns a result of the operation. Each object has a region where internal states (instance variables) of the object itself are stored and where the other objects are not allowed to access.
  • One feature of the object-oriented system is inheritance. For example, an object for drawing a "circle" on a display may inherit functions and knowledge from another object for drawing a "shape" on a display.
  • a programmer "programs" in an object-oriented programming language by writing individual blocks of code each of which creates an object by defining its methods.
  • a collection of such objects adapted to communicate with one another by means of messages comprises an object- oriented program.
  • Object-oriented computer programming facilitates the modeling of interactive systems in that each component of the system may be modeled with an object, the behavior of each component being simulated by the methods of its corresponding object, and the interactions between components being simulated by messages transmitted between objects.
  • An operator may stimulate a collection of interrelated objects comprising an object- oriented program by sending a message to one of the objects.
  • the receipt of the message may cause the object to respond by carrying out predetermined functions, which may include sending additional messages to one or more other objects.
  • the other objects may in turn carry out additional functions in response to the messages they receive, including sending still more messages.
  • sequences of message and response may continue indefinitely or may come to an end when all messages have been responded to and no new messages are being sent.
  • a programmer need only think in terms of how each component of a modeled system responds to a stimulus and not in terms of the sequence of operations to be performed in response to some stimulus. Such sequence of operations naturally flows out of the interactions between the objects in response to the stimulus and need not be preordained by the programmer.
  • object-oriented programming makes simulation of systems of interrelated components more intuitive, the operation of an object-oriented program is often difficult to understand because the sequence of operations carried out by an object-oriented program is usually not immediately apparent from a software listing as in the case for sequentially organized programs. Nor is it easy to determine how an object-oriented program works through observation of the readily apparent manifestations of its operation. Most of the operations carried out by a computer in response to a program are "invisible" to an observer since only a relatively few steps in a program typically produce an observable computer output.
  • the term “object” relates to a set of computer instructions and associated data, which may be activated directly or indirectly by the user.
  • the terms “windowing environment”, “running in windows”, and “object oriented operating system” are used to denote a computer user interface in which information is manipulated and displayed on a video display such as within bounded regions on a raster scanned video display.
  • the terms “network”, “local area network”, “LAN”, “wide area network”, or “WAN” mean two or more computers that are connected in such a manner that messages may be transmitted between the computers.
  • ⁇ typically one or more computers operate as a "server", a computer with large storage devices such as hard disk drives and communication hardware to operate peripheral devices such as printers or modems.
  • Other computers termed “workstations”, provide a user interface so that users of computer networks may access the network resources, such as shared data files, common peripheral devices, and inter- workstation communication.
  • Users activate computer programs or network resources to create “processes” which include both the general operation of the computer program along with specific operating characteristics determined by input variables and its environment.
  • an agent sometimes called an intelligent agent
  • an agent using parameters typically provided by the user, searches locations either on the host machine or at some other point on a network, gathers the information relevant to the purpose of the agent, and presents it to the user on a periodic basis.
  • the term "desktop” means a specific user interface which presents a menu or display of objects with associated settings for the user associated with the desktop.
  • the desktop accesses a network resource, which typically requires an application program to execute on the remote server, the desktop calls an Application Program Interface, or "API", to allow the user to provide commands to the network resource and observe any output.
  • API Application Program Interface
  • the term “Browser” refers to a program which is not necessarily apparent to the user, but which is responsible for transmitting messages between the desktop and the network server and for displaying and interacting with the network user. Browsers are designed to utilize a communications protocol for transmission of text and graphic information over a worldwide network of computers, namely the "World Wide Web" or simply the "Web”.
  • Browsers compatible with the present invention include the Internet Explorer program sold by Microsoft Corporation (Internet Explorer is a trademark of Microsoft Corporation), the Opera Browser program created by Opera Software ASA, or the Firefox browser program distributed by the Mozilla Foundation (Firefox is a registered trademark of the Mozilla Foundation).
  • Internet Explorer is a trademark of Microsoft Corporation
  • Opera Browser program created by Opera Software ASA
  • Firefox browser program distributed by the Mozilla Foundation Firefox is a registered trademark of the Mozilla Foundation.
  • Browsers display information, which is formatted in a Standard Generalized Markup Language (“SGML”) or a HyperText Markup Language (“HTML”), both being scripting languages, which embed non-visual codes in a text document through the use of special ASCII text codes.
  • Files in these formats may be easily transmitted across computer networks, including global information networks like the Internet, and allow the Browsers to display text, images, and play audio and video recordings.
  • the Web utilizes these data file formats to conjunction with its communication protocol to transmit such information between servers and workstations.
  • Browsers may also be programmed to display information provided in an extensible Markup Language (“XML”) file, with XML files being capable of use with several Document Type Definitions (“DTD”) and thus more general in nature than SGML or HTML.
  • XML file may be analogized to an object, as the data and the stylesheet formatting are separately contained (formatting may be thought of as methods of displaying information, thus an XML file has data and an associated method).
  • PDA personal digital assistant
  • WWAN wireless wide area network
  • synchronization means the exchanging of information between a first device, e.g. a handheld device, and a second device, e.g. a desktop computer, either via wires or wirelessly. Synchronization ensures that the data on both devices are identical (at least at the time of synchronization).
  • communication primarily occurs through the transmission of radio signals over analog, digital cellular, or personal communications service (“PCS”) networks. Signals may also be transmitted through microwaves and other electromagnetic waves.
  • PCS personal communications service
  • CDMA code-division multiple access
  • TDMA time division multiple access
  • GSM Global System for Mobile Communications
  • 3G Third Generation
  • 4G Fourth Generation
  • PDC personal digital cellular
  • CDPD packet-data technology over analog systems
  • AMPS Advance Mobile Phone Service
  • Mobile Software refers to the software operating system, which allows for application programs to be implemented on a mobile device such as a mobile telephone or PDA.
  • Examples of Mobile Software are Java and Java ME (Java and JavaME are trademarks of Sun Microsystems, Inc. of Santa Clara, Calif.), BREW (BREW is a registered trademark of Qualcomm Incorporated of San Diego, Calif.), Windows Mobile (Windows is a registered trademark of Microsoft Corporation of Redmond, Wash.), Palm OS (Palm is a registered trademark of Palm, Inc.
  • Symbian OS is a registered trademark of Symbian Software Limited Corporation of London, ETnited Kingdom
  • ANDROID OS is a registered trademark of Google, Inc. of Mountain View, Calif.
  • iPhone OS is a registered trademark of Apple, Inc. of Cupertino, Calif.
  • Windows Phone 7 “Mobile Apps” refers to software programs written for execution with Mobile Software.
  • scan refers to x-ray, magnetic resonance imaging (MRI), computerized tomography (CT), sonography, cone beam computerized tomography (CBCT), or any system that produces a quantitative spatial representation of a patient.
  • MRI magnetic resonance imaging
  • CT computerized tomography
  • CBCT cone beam computerized tomography
  • imaging reference or simply “fiducial” refers to an object or reference on the image of a scan that is uniquely identifiable as a fixed recognizable point.
  • fiducial location refers to a useful location to which a fiducial reference is attached.
  • a “fiducial location” will typically be proximate a surgical site.
  • the term “marker” or “tracking marker” refers to an object or reference that may be perceived by a sensor proximate to the location of the surgical or dental procedure, where the sensor may be an optical sensor, a radio frequency identifier (RFID), a sonic motion detector, an ultra-violet or infrared sensor.
  • RFID radio frequency identifier
  • tracker refers to a device or system of devices able to determine the location of the markers and their orientation and movement continually in ' real time ' during a procedure. As an example of a possible implementation, if the markers are composed of printed targets then the tracker may include a stereo camera pair.
  • the tracker may include a non-stereo optical camera or a stereo camera pair, which may operate in the visible or infrared region of the spectrum.
  • image information is used in the present specification to describe information obtained by the tracker, whether optical or otherwise, about one or more tracking markers and usable for determining the location of the markers and their orientation and movement continually in real time ' during a procedure.
  • ROM read-only memory
  • RAM random access memory
  • BIOS Basic Input-Output system
  • Applications resident with computer system are generally stored on and accessed via computer readable media, such as hard disk drives, optical drives, a floppy disk unit, or other storage medium. Additionally, applications may be in the form of electronic signals modulated in accordance with the application and data communication technology when accessed via a network modem or interface or other telecommunications equipment (not shown).
  • a storage interface may connect to standard computer readable media for storage and/or retrieval of information, such as a fixed disk drive.
  • the fixed disk drive may be part of a computer system or may be separate and accessed through other interface systems.
  • a modem may provide direct connection to remote servers via telephone link or the Internet via an Internet service provider (ISP).
  • ISP Internet service provider
  • a network interface may provide direct connection to remote servers via direct network link to the Internet via a POP (point of presence).
  • a network interface may provide such connection using wireless techniques, including digital cellular telephone connection, Cellular Digital Packet Data (CDPD) connection, digital satellite data connection or the like.
  • CDPD Cellular Digital Packet Data
  • Many other devices or subsystems may be connected in a similar manner (e.g., document scanners, digital cameras and so on), including hardware components, which alternatively may be in communication with associated computational resources through local, wide-area, or wireless networks or communications systems.
  • the hardware components may be directly connected or remotely connected with computing resources.
  • Software source and/or object codes to implement the present disclosure may be stored in computer-readable storage media such as one or more of a system memory, fixed disk, optical disk, or floppy disk.
  • the operating system provided on computer system 210 may be a variety or version of either MS-DOS.RTM. (MS-DOS is a registered trademark of Microsoft Corporation of Redmond, Wash.), WINDOWS. RTM.
  • WINDOWS is a registered trademark of Microsoft Corporation of Redmond, Wash.
  • OS/2.RTM is a registered trademark of International Business Machines Corporation of Armonk, N. Y.
  • UNIX.RTM UNIX is a registered trademark of X/Open Company Limited of Reading, United Kingdom
  • Linux.RTM (Linux is a registered trademark of Linus Torvalds of Portland, Oreg.), or other known or developed operating system.
  • a signal may be directly transmitted from a first block to a second block, or a signal may be modified (e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified) between blocks.
  • a signal may be directly transmitted from a first block to a second block, or a signal may be modified (e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified) between blocks.
  • modified signals e.g., amplified, attenuated, delayed, latched, buffered, inverted, filtered, or otherwise modified
  • a signal input at a second block may be conceptualized as a second signal derived from a first signal output from a first block due to physical limitations of the circuitry involved (e.g., there will inevitably be some attenuation and delay). Therefore, as used herein, a second signal derived from a first signal includes the first signal or any modifications to the first signal, whether due to circuit limitations or due to passage through other circuit elements which do not change the informational and/or final functional aspect of the first signal.
  • the present invention also contemplates microdot projector mapping of lumen based organs via the endoscope of the present invention.
  • a probe that had a microdot projector may fit through a channel or attached the tip of a camera.
  • US Patent Publication 20160296692 discloses a system for injecting fluid to a patient. The system provides manual or automatic verification and identification of the fluid to be injected, prior to, during or after injection.
  • the system includes: a fluid having at least one active compound and at least one tracer compound; an injector configured to deliver the fluid to the patient through a fluid path set; at least one sensor coupled to at least one of the syringe, the injector, or the patient, configured to measure at least one property of the tracer in the fluid, and a feedback path to adjust at least one injection parameter of the injector based on at least one measurement from the at least one sensor.
  • the at least one sensor may be coupled to a tissue section of a patient, such as, for example a dermal tissue section of a patient.
  • the at least one sensor may be associated with an internal tissue section of the patient, such as where the at least one sensor is on an endoscope, catheter or other medical device inserted within the patient.
  • the at least one sensor may be configured to measure in vivo at least one property of the injection fluid such as, for example a concentration of the tracer compound at a site within the patient near the tissue section, a location of the tracer compound within a vascular system of the patient near the tissue section, an extravasation of the tracer compound outside of the vascular system of the patient near the tissue section, or combinations of any thereof.
  • Microdots and micro-labels may be printed or laser-etched to the surface of the syringe barrel for proper identification.
  • Microdots are microscopic particles, which are typically about one thousand microns in size and include alpha-numeric sequences.
  • the microdots may be printed or laser-etched to a surface to form a barcode-like structure.
  • Various sensors may be used to extract data about the barcode-like structure.
  • microdots can include voids within molded dots that reflect various wavelengths of light in readily identifiable patterns.
  • the injector may include a light source at a specific wavelength and sensors configured to measure the predefined reflection. The type of reflection could be used to provide additional information about the syringe or fluid solution. The information may be used for identification and authentication purposes.
  • US Patent Publication 20050221279 discloses a method for creating chemical sensors using contact-based microdispensing technology.
  • Contact based rigid pin tool technology is utilized to print one or more indicator chemistries on an optical array or a disposable sheath configured on such arrays.
  • Each indicator chemistry contains predetermined material, such as, light energy absorbing dye(s), optically responsive particles, etc., whose optical characteristics change in response to the target ligand or analyte.
  • predetermined material such as, light energy absorbing dye(s), optically responsive particles, etc.
  • the sensor portion contained in a probe capable of accessing the desired sample.
  • the sensor for example, can be incorporated in a mechanical periodontal probe for sampling the gingival crevicular fluid and saliva; a needle for accessing tissue; a catheter, endoscope, or guidewire for monitoring blood constituents; a cone penetrometer for making soil gas measurements; or a down well sampler for groundwater monitoring, among others.
  • a fiber optic bundle is a natural choice for these applications, since fibers can guide light long distances with minimal loss of intensity and are very compact.
  • An optical array such as a standard fiber imaging bundle, may contain lOOO's of individually clad optical fibers in a small diameter bundle ( ⁇ 500 .mu.m).
  • each microdot overlays at least one imaging fiber the orientation (i.e. rotation) of the bundle tip relative to the rigid tool printing element becomes less important, making sensor manufacture much easier and allowing many more indicator microdots to be placed in a given area.
  • the microdots can either be printed directly on the distal end of the fiber bundle or printed on the tip of a disposable sleeve (e.g. plastic) that can be slipped over the end of the imaging fiber bundle.
  • a user can create and visualize a customized pattern of microdots simply by using a drag-and-drop tool from a palette of up to conceivably 1596 color-coded chemistries.
  • Each chemistry is color-coded, as specified by the user, within the software and mapped to one well in a standard well plate.
  • the user can save this pattern to a file, or load a previously saved pattern to the pattern editor.
  • individual dots can be selected and the position finely tuned by adjusting coordinates.
  • the order in which microdots are printed is determined by the placement order in the pattern editor. In multi-chemistry printing, all microdots of like chemistries are printed in sequence.
  • An automated routine executes a single printing cycle for each indicator chemistry specified in a desired custom pattern.
  • the printing cycle includes chemistry pickup from a specified well in a well plate, conditioning the sample delivery of the rigid tool by printing a specified number of microdots on a predetermined blotting substrate (e.g., a glass slide), printing the desired microdot configuration on a predetermined optical array, such as, for example, optical fiber bundles, and cleaning the rigid pin printing tool according to a user specified wash cycle before the next chemistry pickup.
  • a user can specify which wells are used for sample pickup, the stages in a wash cycle, the conditioning procedure, the descent speed of the rigid tool during printing, and the amount of time the tool rests on the printing surface. It is possible to pause the automated routine, make modifications to the pattern or wash cycle, realign the rigid tool and optical array, or manually position the rigid tool before resuming the routine.
  • Spectroscopic measurements can be made using, for example, an imaging spectrometer.
  • Microdots of the present invention are often micron sized (e.g., less than about 500 microns) but can be nano-sized particles (e.g., about 100 nanometers) of polymer spots that can, but not necessarily are required to, contain an indicator as disclosed herein.
  • Such microdots can also be arranged to include additional layers (i.e., one or more layers) of either a polymer membrane (e.g., a hydrophobic membrane applied to a polymerized microdot that includes an indicator immobilized in a hydrophilic membrane) and/or an indicator immobilized in a polymer (i.e., an indicator chemistry) applied to a polymerized spot.
  • a polymer membrane e.g., a hydrophobic membrane applied to a polymerized microdot that includes an indicator immobilized in a hydrophilic membrane
  • an indicator immobilized in a polymer i.e., an indicator chemistry
  • Such an example embodiment in the former case can be
  • Endoscopic devices and/or elements thereof described herein may be used in conjunction with a system.
  • Endoscopic systems may include multiple elements as outlined herein.
  • Subjects were instructed to not eat or drink for 2 hours prior to the TNE.
  • subjects were asked to sit in a chair designed for outpatient laryngoscopic procedures.
  • Two to six sprays of 4% aerosolized lidocaine were applied to the nares to achieve topical anesthesia.
  • Subject distraction was accomplished using either HMZ-T3W 3D movie goggles (Sony Corporation, Tokyo, Japan) or Cinemizer Goggles (Carl Zeiss AG, Oberkochen, Germany) dependent on facial size to facilitate viewing an immersive movie or television program of their choice. Parents remained in the room for the duration of the study.
  • ED pulmonologists
  • JP otolaryngologist
  • Olympus BFXP160F 2.8 mm bronchoscope (1.2 mm biopsy channel) in 11/21 subjects and 10/21 subjects using a 4 mm BPMP160F (2 mm biopsy channel) ending with the endoscope in the proximal esophagus.
  • the gastroenterologist (JF) performed esophagoscopy and biopsy collection (3 from proximal and 3 from distal esophagus). Visual confirmation of the adequacy of the biopsy specimens was performed before withdrawing scope.
  • Adverse events, subject symptoms, duration of TNE in 5 minute intervals up to 15 minutes were collected. After the procedure, families were asked to answer the mGHAA-9 (modified Group Health Association of America) endoscopy satisfaction questionnaire and discharged home.
  • a single pediatric pathologist evaluated biopsy specimens to assess for size of the sample and inflammatory findings including eosinophil enumeration.
  • KC pathologist
  • the total epithelial surface area used to count eosinophils was analyzed using graphical software and analysis (cellSens Standard, 2013, Olympus America, EISA). This was accomplished by comparing the subject’s available previous esophageal biopsies using a standard 2.8 mm biopsy forceps to the 1.2 or 2mm biopsy forceps specimens that were collected during TNE.
  • TNE procedures decreased as the endoscopists (JF, ED, JP, RD) became more experienced with TNE. (Table 2). The youngest child was 8 years old and was able to tolerate the 4 mm endoscope without difficulty. Symptoms associated with the TNE included gagging and sore throat (Table 3). No adverse event was associated with any emergency department evaluation or unintended evaluation or treatment. One subject had a panic attack prior to the procedure but was still able to complete the TNE without any additional medication. She had a previous history of an anxiety disorder.
  • Post-procedure assessment revealed a high degree of satisfaction and comfort with the TNE immediately after and at subsequent survey.
  • a high percentage of subjects reported satisfaction with TNE, child subjects (81%) and parents (90.5%). This is as compared to 81% of combined parent/child subjects satisfied with their previous sedated EGD when asked about it at time of TNE survey.
  • Subjects expressed greater concerns for EGD than TNE on qualitative instrument 61.9% vs. 28.6 % respectively). The majority of children (76.2%) would repeat TNE and 100% of parental subjects were willing to have their child undergo the procedure again.
  • Visual TNE findings revealed 11 subjects with normal esophagoscopy, 9 with furrowing and one with furrowing and exudates. Visual findings correlated to the appropriate histologic findings in 85.7% of subjects. In those subjects where visual and histological findings did not correlate, 2 subjects with visual furrowing had normal biopsies, and one with normal appearing mucosa showed histological evidence of eosinophilia ⁇ 15 eos hpf. (Image 1, Table 5)
  • Biopsy specimens revealed 12 normal biopsies, 4 with less than 15 eosinophils per hpf, and 5 with greater than 15 eosinophils per hpf.
  • Table 5, Image 1 No significant difference was identified when comparing total epithelial surface area of TNE biopsies to the biopsy surface area of the matched subject’s previous EGD.
  • Table 5 One subject that was initially evaluated at an outside institution did not have his previous biopsies available for analysis. Total epithelial surface area of mucosal biopsies samples from TNE forceps compared to those obtained with standard endoscopic forceps was not statistically different. (0.33 mm 2 +/- 0.09 vs.

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Abstract

Un dispositif d'endoscope/triplescope (gastroscope, bronchoscope, laryngoscope combinés) et/ou un système comprend un endoscope ayant un diamètre extérieur inférieur à environ 5,0 millimètres, en particulier inférieur à environ 3,5 millimètres, ayant un élément d'éclairage qui comprend au moins une microDEL ce qui permet une visualisation haute résolution ayant un élément distal comprenant un élément optique qui permet une déviation de pointe à quatre voies. En fonction de l'utilisation, la lumière émise par les microDEL ou les multiples microDELs peut être commandée de telle sorte qu'une longueur d'onde particulière ou une plage de longueurs d'onde est émise. En outre, le dispositif peut comprendre un appareil de raidissement de scope pour minimiser la flexibilité d'endoscopes lorsque cela est nécessaire, un une activation par pied et par main pour permettre une insufflation d'air/eau et une capture d'image/vidéo, une source de lumière, un conduit intérieur ayant un diamètre supérieur à environ 2 mm, un ou plusieurs réseaux de capteurs, des éléments audio pour la transcription de rapport, des capteurs pour mesurer des résultats de cavité corporelle.
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113180580A (zh) * 2021-04-25 2021-07-30 西安医学院 一种用于口腔及喉镜内科检测的装置及照明方法
EP4302674A1 (fr) * 2022-07-05 2024-01-10 Ambu A/S Endoscope ayant une unité de pointe distale comprenant une partie bombée

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